Method for anastomosing vessels

ABSTRACT

A method for connecting a graft vessel to a target vessel, each vessel having a wall surrounding a lumen, may include providing a connector holder, associating an end of the graft vessel with the connector holder, positioning the connector holder outside of the lumen of the target vessel, outside the lumen of the graft vessel, and in proximity to the outer surface of the wall of the target vessel, and actuating the connector holder to secure the end of the graft vessel to the side of the target vessel.

This application is a continuation of U.S. patent application Ser. No.10/392,336, which in turn is a continuation-in-part of U.S. patentapplication Ser. No. 10/151,441, which in turn is a continuation-in-partof U.S. Pat. No. 6,391,038. Additionally, this application claimspriority to U.S. Provisional Patent Application Ser. No. 60/399,880,filed on Jul. 31, 2002.

FIELD OF THE INVENTION

The invention relates to an apparatus and method for performinganastomosis.

BACKGROUND

Anastomosis is a procedure by which two hollow tissue structures arejoined together. More particularly, vascular anastomosis is a procedureby which two blood vessels within a patient are surgically joinedtogether. Vascular anastomosis is performed during treatment of avariety of conditions including coronary artery disease, diseases of thegreat and peripheral vessels, organ transplantation, and trauma. Incoronary artery disease (CAD) an occlusion or stenosis in a coronaryartery interferes with blood flow to the heart muscle. Treatment of CADinvolves the grafting of a vessel in the form of a prosthesis orharvested artery or vein to reroute blood flow around the occlusion andrestore adequate blood flow to the heart muscle. This treatment is knownas coronary artery bypass grafting (CABG).

In the conventional CABG, a large incision is made in the chest and thesternum is sawed in half to allow access to the heart. In addition, aheart-lung machine is used to circulate the patient's blood so that theheart can be stopped and the anastomosis can be performed. In order tominimize the trauma to the patient induced by conventional CABG, lessinvasive techniques have been developed in which the surgery isperformed through small incisions in the patient's chest with the aid ofvisualizing scopes. In both conventional and less invasive CABGprocedures, the surgeon has to suture one end of the graft vessel to thecoronary artery and the other end of the graft vessel to ablood-supplying artery, such as the aorta. The suturing process is atime consuming and difficult procedure requiring a high level ofsurgical skill. In order to perform the suturing of the graft to atarget vessel such as the coronary artery or the blood supplying artery,a surgeon holds the edges of the incision in the target vessel with onehandle and holds a needle in the other hand for suturing, or anassistant may hold the edges of the incision in the target vessel whilea surgeon makes small stitches as close as possible to the edges of theincision. This suturing requires a high degree of precision and is quitetime consuming. In addition, during conventional CABG procedures bloodflow at the anastomosis site is stopped during suturing. This preventsbleeding from the incision site but also prevents blood from reaching aportion of the heart muscle served by the vessel. Further, duringoff-pump CABG procedures a side clamp or other device may be used toisolate a portion of the wall of the aorta to which a graft vessel issutured. The use of a side clamp or similar device can cause emboli todetach from the wall of the aorta and enter the bloodstream, which isundesirable.

Accordingly, it would be desirable to provide a vascular anastomosissystem that allows the tissue at the anastomosis site to be controlledduring suturing or other connection of the graft and target vessels. Itwould also be desirable to provide a vascular anastomosis system thatallows the connection of a graft vessel to a target vessel prior tomaking an incision in the target vessel which allows blood flow betweenthe target vessel and the graft vessel.

SUMMARY OF THE INVENTION

In one aspect of the invention, an anastomosis tool includes a tissueeffector connected to a handle by a shaft or other structure. The tissueeffector may be orientable relative to the handle and/or shaft. Forexample, the tissue effector may be configured to roll, pitch and/or yawrelative to the shaft. In this way, the tissue effector can be placed ina desired orientation at an anastomosis site, and the handle can be heldin a convenient position by the user.

In another aspect of the invention, the tissue effector includes astaple holder moveable relative to an anvil. The staple holder holds atleast one staple. The staple holder and the anvil are movable relativeto one another, and move between an open position and a closed position.In the open position, the anvil is configured for insertion into atarget vessel. The tissue effector may be biased to the open positionwith a spring or other mechanism or structure. In the closed position,the tissue effector holds the graft vessel against the wall of thetarget vessel.

In another aspect of the invention, the staple holder includes two ormore spaced-apart arms. An end of the graft vessel is cut to form atleast one flap therein, and each flap is folded onto an arm of thestaple holder. One or more graft clips are provided on each arm, whereeach graft clip secures a corresponding flap to the surface of the arm.Each clip is configured to move between an open position for receiving aflap and a closed position for securing the flap to the correspondingarm of the staple holder. Each graft clip may utilize a cam-lock featureor other structure or mechanism to hold itself in the closed position.One or more spikes may be provided on each arm, such that the spike orspikes penetrate and hold the corresponding flap to secure it morethoroughly to the staple holder.

In another aspect of the invention, at least one of the arms of thestaple holder includes at least one connector bay. A staple is heldwithin each connector bay, such as by friction against its walls. One ormore of the staples may be coated with sodium stearate or otherbiocompatible lubricant. A passage extends though each arm of the stapleholder, where one end of each connector bay opens to that passage.

In another aspect of the invention, a connector deployer extends intoeach connector bay, such that one end of the connector deployer contactsor is in proximity to the corresponding staple. One end of eachconnector bay faces the anvil when the tissue effector is in the closedposition, and the other end of each connector bay opens to a channel orother structure. The ends of the connector bays facing the anvil areagainst or in proximity to the flaps of the graft vessel held againstthe arms of the staple holder, such that deployment of the staples fromthe connector bays causes those staples to penetrate the flaps.

In another aspect of the invention, a ramp element is movable withineach passage. The ramp element may be a component of a sled that ismovable relative to the staple holder. Upon contacting a connectordeployer, the ramp element urges it into the connector bay. In turn,that connector deployer urges the corresponding staple along theconnector bay and out of the open end of the connector bay. As the rampelement translates along the channel, it sequentially encounters theconnector deployers, thereby sequentially deploying the staples into thecorresponding flap and into the wall of the target vessel. Alternately,at least one ramp element may be configured to deploy the staples inanother manner, such as substantially simultaneously.

In another aspect of the invention, excess tissue may be incised fromthe flaps of the graft vessel. Such incising may be performed before,during or after the connection of the graft vessel to the target vessel.For example, a vein knife is configured to move relative to a secondchannel defined in an arm of the staple holder, where the second channelis positioned relative to the flap such that the flap can be to adesired size. Each flap may be incised during or after the anastomosis,freeing the graft vessel from the staple holder. The vein knife may beconnected to the sled directly or indirectly. Thus, as the sledtranslates along the first channel, the vein knife translates along thesecond channel and incises the corresponding flap.

In another aspect of the invention, at least one graft clip bladeoptionally is attached to at least one of the arms of the staple holder.The graft clip blade has a serrated edge oriented to engage thecorresponding flap of the graft vessel. The serrations on the edge ofthe graft clip blade assist in holding the corresponding flap securely,particularly as the vein knife incises excess tissue from the flap.Additionally, the graft clip blade may participate in incising excesstissue from the corresponding flap. Further, the serrations on the edgeof the graft clip blade, in conjunction with the spikes, may assist inholding the excess tissue incised from each flap.

In another aspect of the invention, a cutter translates along a slot inthe anvil to create an opening in the wall of the target vessel. Thetiming of the staple deployments are coordinated with the motion of thecutter. As one example, the sled and the cutter move simultaneously. Thesled and the cutter are shaped, positioned and/or otherwise configuredto connect the graft vessel to the target vessel and to incise anopening in the wall of the target vessel in a coordinated manner.

In another aspect of the invention, the distal end of one or more of thearms of the staple holder may be notched. After the staples have beendeployed, the sled may be positioned such that its distal ends arelocated at the distal ends of the channels, such that the sled isvisible via the notches. In this way, actuation of the sled and thusdeployment of the staples can be visually confirmed.

In another aspect of the invention, the handle includes a triggeroperationally connected to the tissue effector, providing for actuationof the tissue effector with a single motion of the trigger. That is, asingle input to the anastomosis tool both deploys staples and incisesthe target vessel at the anastomosis site, such that a single input tothe tool creates a complete anastomosis between the graft vessel and thetarget vessel.

In another aspect of the invention, the trigger is connected to a rockerthat is configured to engage a proximal slider during actuation of thetrigger. A first cable or other force transmission structure ormechanism is connected to the proximal slider, as well as to the anvil.The first cable is movable relative to a cable housing, which is fixedat one end to the staple holder and at the other end to the shaft. Theanvil is fixed relative to the shaft as well. As the trigger isactuated, the rocker urges the proximal slider proximally, causing theproximal slider to pull the first cable proximally. Because the anvil isfixed relative to the shaft, the proximal motion of the first cabletensions the first cable. Because the cable housing is fixed to thestaple holder, the tensioning of the first cable causes the stapleholder to move closer to the anvil, thereby moving the tissue effectorfrom the open position to the closed position. By moving the stapleholder and keeping the anvil substantially stationary, the tissueeffector closes without damaging the target vessel within which theanvil is positioned.

In another aspect of the invention, the rocker is configured to engage adistal slider during actuation of the trigger. A second cable or otherforce transmission structure or mechanism is connected to the distalslider, as well as to the sled. As the trigger is actuated, the rockerreleases the distal slider to move proximally, causing the distal sliderto pull the second cable proximally. The second cable is routed over abend on the staple holder such that the motion of the second cable pullsthe sled in the distal direction.

In another aspect of the invention, the flaps are decoupled from thetissue effector after the anastomosis is complete. Advantageously, thisdecoupling occurs as a result of the depression of the trigger, suchthat a single control is used to perform the entire anastomosisprocedure. Decoupling may be performed by incising the flaps, byreleasing the graft clips, or in any other appropriate manner.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an anvil and a plurality of staplesaccording to a first aspect of the present invention.

FIG. 2 is a perspective view of the anvil of FIG. 1 being inserted intoa target vessel.

FIG. 3 is a perspective view of the anvil tenting a wall of a targetvessel for an anastomosis procedure.

FIG. 4 is a perspective view of a graft vessel placed adjacent anexterior of the tented target vessel for the anastomosis procedure.

FIG. 5 is a perspective view of the staples being applied to the graftvessel and the target vessel during an anastomosis procedure.

FIG. 6 is a perspective view of the completed anastomosis according tothe first aspect of the present invention.

FIG. 7 is a perspective view of a staple supported on a staple holdingstrip.

FIG. 8 is a side view of the staple and staple holding strip of FIG. 7when the ends of the staple have been bent by contact with an anvil.

FIG. 9 is a perspective view of an anvil and staple according to anotheraspect of the present invention.

FIGS. 10A and 10B are is a side views of a plurality of staplessupported on two examples of expandable staple holding strips.

FIG. 11 is a perspective view of a portion of an anvil having a movablecutting device.

FIG. 12 is a side view of an anvil having an external cutting device.

FIGS. 12A and 12B are side views of a portion of an anvil and twocutting devices that snap onto the anvil.

FIG. 13 is a side view of a portion of an anvil with an extendablecutting device.

FIG. 14 is a side view of the anvil of FIG. 13 with the cutting deviceextended.

FIG. 15 is a side view of a portion of an anvil with an alternateextendable cutting device.

FIG. 16 is a side view of the anvil of FIG. 15 with the cutting deviceextended.

FIG. 17 is a perspective view of an anvil according to a second aspectof the invention being inserted into a target vessel.

FIG. 18 is a perspective view of the anvil of FIG. 17 positioning insidea target vessel and a clamp being advanced to clamp the wall of thetarget vessel between the anvil and the clamp.

FIG. 19 is a perspective view of a graft vessel being advanced to thetarget vessel with a continuous anastomosis staple while the anastomosissite on the target vessel is controlled by the anvil and clamp.

FIGS. 20-22 are side cross sectional views of the steps of performingthe anastomosis with the continuous anastomosis staple shown in FIG. 19.

FIG. 23 is a perspective view of the completed anastomosis performed asshown in FIGS. 19-22.

FIGS. 24-27 are perspective views of the steps of an alternative anviland clamp system for controlling an anastomosis site and forming anincision through the clamped tissue of the target vessel.

FIG. 28 is a perspective view of a system for controlling a tissue siteand performing anastomosis according to the present invention.

FIG. 29 is a cross sectional view taken along line C-C of FIG. 28,showing a first step of the anastomosis procedure.

FIG. 30 is a cross sectional view taken along line C-C of FIG. 28,showing a second step of the anastomosis procedure.

FIG. 31 is a cross sectional view taken along line C-C of FIG. 28,showing a third step of the anastomosis procedure.

FIG. 32 is a perspective view of an anvil according to another aspect ofthe present invention for use with sutures.

FIG. 33 is a perspective view of the anvil of FIG. 32 positioned withina target vessel and used to locate a plurality of suture at ananastomosis site.

FIG. 34 is a side cutaway view of a first embodiment of an anvil, acutter and a staple holder, where the anvil and staple holder are spacedapart from each other.

FIG. 35 is an end cross-section view of the anvil of FIG. 34.

FIG. 36 is a side cutaway view of a portion of the anvil inserted intothe lumen of a target vessel.

FIG. 37 is a side view of the cutter.

FIG. 38 is a perspective view of the cutter of FIG. 37.

FIG. 39 is a side view of the distal end of a second embodiment of acutter.

FIG. 40 is a side view of the distal end of a third embodiment of acutter.

FIG. 41 is a side view of the distal end of a fourth embodiment of acutter.

FIG. 42 is a side view of a portion of a fifth embodiment of a cutter.

FIG. 43 is a side view of the distal end of a sixth embodiment of acutter.

FIG. 43A is a side view of another embodiment of a cutter.

FIG. 43B is a side view of another embodiment of a cutter.

FIG. 44 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a first position.

FIG. 45 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a second position.

FIG. 46 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a third position.

FIG. 47 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a fourth position.

FIG. 48 is a side cutaway view of the anvil and staple holder of FIG.34, where the cutter is in a fifth position.

FIG. 49 is a side cutaway view of a second embodiment of an anvil and astaple holder, where the anvil and staple holder are spaced apart fromeach other.

FIG. 50 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a first position.

FIG. 51 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a second position.

FIG. 52 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a third position.

FIG. 53 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a fourth position.

FIG. 54 is a side cutaway view of the anvil and staple holder of FIG.40, where the cutter is in a fifth position.

FIG. 55 is a side view of an anastomosis tool having a tissue effectorand a handle.

FIG. 56 is a perspective view of the tissue effector of FIG. 55 in firstposition.

FIG. 57 is a perspective view of the tissue effector of FIG. 55 in asecond position.

FIG. 58 is another perspective view of the tissue effector of FIG. 55 inthe first position.

FIG. 59 is a perspective view of the tissue effector of FIG. 55 in thefirst position, with a graft vessel being connected to it.

FIG. 59A is a detail cross-section view of a cam lock used in the tissueeffector of FIG. 55, where the cam lock is in an open position.

FIG. 59B is a detail cross-section view of the cam lock of FIG. 59A in aclosed position.

FIG. 59C is an end view of the left half of the tissue effector of FIG.55, in the closed position.

FIG. 59D is an end view of the right half of another embodiment of thetissue effector of FIG. 55, in the closed position.

FIG. 60 is a detail side view of a portion of the tissue effector ofFIG. 55, showing an embodiment of a graft clip.

FIG. 61 is a detail end view of a portion of the tissue effector of FIG.55.

FIG. 62 is a side view of a vein knife used in the tissue effector ofFIG. 55.

FIG. 63 is a side view of a graft clip blade used in the tissue effectorof FIG. 55.

FIG. 64 is a cross-section view of section A-A of FIG. 57.

FIG. 65 is a perspective view of a connector deployer used in the arm ofFIG. 64.

FIG. 66 is a side view of a portion of the arm of FIG. 64 as defined bythe line B-B of FIG. 64.

FIG. 67 is a perspective view of a staple configured to be deployed fromthe tissue effector of FIG. 55.

FIG. 68 is a perspective view of a sled used in the tissue effector ofFIG. 55.

FIG. 69 is a bottom view of the sled of FIG. 68.

FIG. 69A is a side view of the sled of FIG. 68.

FIG. 70 is a side cross-section view of the handle of FIG. 55 in a firstposition.

FIG. 71 is a top view of a portion of a rocker utilized in the handle ofFIG. 55.

FIG. 72 is a side cross-section view of the handle of FIG. 55 in asecond position.

FIG. 73 is a perspective view of a completed anastomosis.

FIG. 74 is a perspective view of the tissue effector of FIG. 55 with agraft vessel loaded onto it.

FIG. 75 is a perspective view of the tissue effector of FIG. 74, wherethe anvil of the tissue effector has been inserted into the lumen of atarget vessel.

FIG. 76 is a perspective view of the tissue effector of FIG. 74, afterthe graft vessel has been connected to the target vessel and before theanvil of the tissue effector has been removed from the lumen of thetarget vessel.

FIG. 77 is a graph qualitatively illustrating the positions of thedistal slider and the proximal slider of the handle over time, withregard to an arbitrary point between them.

FIG. 78 is an exploded view of the handle of the anastomosis tool. Theuse of the same reference symbols in different figures indicates similaror identical items.

DETAILED DESCRIPTION

As shown in FIG. 1, one embodiment of an anvil 10 includes a handle 12and an anvil arm 14 extending from the handle 12. The anvil arm 14 maybe oriented substantially perpendicular to the handle 12, or oriented ata different angle. The anvil arm 14 may be provided with one or morestaple bending features 16 on opposite sides of the anvil arm 14. In theanvil 10 shown in FIG. 1, the staple bending features 16 each include aplurality of recesses 20 which receive the ends of staples 22 and causethe staple ends to bend over. At least one of the staple bendingfeatures 16 may be configured differently or omitted, if desired. Thestaples 22 may be connected to a staple holding strip 24. The staples 22are U-shaped and are arranged in a spaced apart parallel configurationsuch that the staples 22 all lie in a single plane. Alternately, thestaples 22 may be shaped differently, and/or lie in one or moredifferent planes. An exemplary anvil arm 14 has a height and a width ofabout 2 mm or less, advantageously about 1 mm or less, and a length ofabout 2 to 15 mm, advantageously 5 to 12 mm. The length of the anvilwill vary depending on the diameter of the graft vessel selected. Thelength to width ratio of the anvil arm 14 is substantially between 2:1and 15:1. A different length to width ratio may be used, if desired. Asone example, the staples 22 have widths of about 0.2-3 mm.Advantageously, the staples 22 have widths of substantially 2 mm orless. The leg lengths of the staples 22 are substantially 0.2-3 mm.Alternately, other staple widths and/or leg lengths may be used.

The anvil arm 14 has a sharp distal end 28 for puncturing the tissue ofa target vessel to insert the anvil arm 14 into the target vessel. Asillustrated in FIG. 2, the anvil arm 14 is inserted into a pressurizedor unpressurized target vessel 30 by puncturing the target vessel withthe distal end 28 of the anvil arm 14. The hole that is formed in thewall of the target vessel 30 by the anvil arm 14 is small enough toprevent significant bleeding through the puncture site. Alternately, thehole is closed by hand suturing. Alternately, the hole is closed with abiocompatible glue, adhesive or the like. Alternately, the hole isclosed with a clip, clamp, or other implantable device that remains onthe target vessel. Such a device may be positioned on the outer surfaceand/or inner surface of the target vessel, and may extend into the hole.A device for closing the hole may be constructed from nitinol or othersuperelastic or pseudoelastic material, or from stainless steel or othermaterial, where that device moves between a first configuration and asecond configuration during deployment, and where the secondconfiguration holds the hole closed. The hole is less than substantially2 mm wide, and advantageously less than 1 mm wide. Alternately, theanvil arm 14 has a blunt distal end 28 that is inserted through a holecreated with a separate instrument, by a different instrument connectedto the anvil arm 14, or by a sharp member connected to the anvil arm 14that can be retracted into the anvil arm 14 or otherwise blunted orconcealed after puncturing or creating an incision in the wall of thetarget vessel.

Once the anvil arm 14 has been inserted into the target vessel 30, theanvil arm 14 may be pulled against an inner wall of the target vessel30, causing tenting of the thin tissue of the vessel wall as illustratedin FIG. 3. This tenting of the vessel wall provides control over theanastomosis site during an anastomosis procedure that is described withrespect to FIGS. 4-6. However, tenting of the target vessel wall neednot be tented in order to control the anastomosis site during theanastomosis procedure.

As shown in FIG. 4, a graft vessel 32 is advanced to the anastomosissite and an end 34 of the graft vessel 32 is positioned adjacent anexterior surface of the target vessel 30 at the anastomosis site. Thetented portion of the target vessel 30 is positioned within theperimeter of the end 34 of the graft vessel 32. As shown in FIG. 5, astaple holder 38 is provided having two arms 40 which are pivotallyconnected to the handle 12 of the anvil 10. Alternatively, the pivotingarms 40 of the staple holder 38 may be connected to the handle 12 in adifferent way, or may be connected to a separate or additional device.The arms 40 are spaced apart from one another across at least a part oftheir length. Thus, the graft vessel can be positioned between the arms40. That is, the arms 40 are positioned on substantially opposite sidesof the graft vessel. In this way, each arm 40 may be positioned againsta flap at an end of the graft vessel, as illustrated in FIGS. 29-31. Thearms 40 may be configured differently, if desired.

Referring also to FIG. 1, the staple holder 38 may be used to holdindividual staples 22 and/or staple holding strips 24. In oneembodiment, each arm 40 of the staple holder 38 carries one row ofstaples 22 or one staple holding strip 24, where the staples 22 arearranged in a substantially linear row. Alternately, staples 22 orstaple strips 24 may be arranged in two or more rows, parallel orotherwise, on one or more arms 40. Alternately, the staples 22 may bestaggered on one or more arms, such that at least one row of staples 22does not fall along a straight line. The staples 22 or staple strips 24may be arranged or aligned in any manner on each arm 40 that results ina secure anastomosis between the graft vessel and the target vessel. Thestaples 22 are inserted through the flaps at the end of the graft vessel32, or another portion of the target vessel, and into the target vessel30 by pivoting the arms 40 of the staple holder 38 towards the anvil arm14. The staple bending features 16 are positioned in a configurationcorresponding to the configuration of the staples 22, such that eachstaple 22 engages a corresponding staple bending feature 16 duringdeployment. When the ends of the staples 22 engage the staple bendingfeatures 16 on the anvil arm 14, the ends of the staples 22 are bentover, securing the graft vessel 32 and target vessel 30 together. Oncethe staple ends are bent over, the staples 22 are released from thestaple holding strip 24 or the staple holder 38, resulting in spacedapart staples 22 securing the graft vessel 32 and the target vessel 30together as shown in FIG. 6. Alternately, the staple holder 38 is amechanism that deploys connectors other than or in addition to staples22.

After stapling is complete, an incision is formed in the wall of thetarget vessel 30 to allow blood flow between the target vessel and thegraft vessel 32. Some examples of methods and devices for forming theincision will be described in further detail below. FIG. 6 illustrates acompleted anastomosis between a target vessel 30 and a graft vessel 32with a plurality of staples 22. The spacing between the staples 22 isapproximately 1 to 4 mm. This spacing is similar to the spacing betweensutures in a conventional sutured anastomosis. A different spacingbetween the staples 22 may be used if desired. After completion of theanastomosis, the anvil arm 14 is withdrawn from the target vessel 30between adjacent staples 22. The withdrawal of the anvil arm 14 leaves agap that is approximately the same as the spacing between adjacentstaples. Accordingly, substantially no blood leakage occurs at thelocation where the anvil arm has been withdrawn.

FIGS. 7 and 8 illustrate one example of a staple 22 connected to astaple holding strip 24. This staple 22 includes barbed staple ends 52extending from the front portion of the staple 22 and a C-shaped portion54 extending from a rear of the staple 22 for connecting the staple 22to the staple holding strip 24. The staple holding strip 24 includes aplurality of protrusions 56 for receiving the staples 22. The C-shapedportion 54 of each staple 22 is received around one of the protrusions56 and is secured in place at one or more locations, such as by welds 58or by a frangible linkage or connection. Alternately, the C-shapedportion 54 of each staple 22 may be secured to the staple-holding strip24 in a different way. As shown in FIG. 8, when the staple holding strip24 is advanced toward the anvil arm 14, the barbed staple ends 52 arereceived in the recesses 20 in the anvil arm 14. Contact between eachstaple end 52 and the corresponding recess 20 generates a moment thatcauses the barbed staple ends 52 to bend towards one another. At thesame time that the barbed staple ends 52 bend over, or after the bendingof the staple ends 52, the staple 22 is detached from the staple holdingstrip 24. The staple 22 may be detached from the staple holding strip 24by the action of bending the barbed staple ends 52 such that theC-shaped portion 54 of the staple 22 splays outward and breaks apartfrom the corresponding protrusion 56 on the staple holding strip 24, bybending a frangible connection between the staple holding strip and thestaples to separate the staples, or any other known separation methods,such as melting of a connection between the staple and the stapleholding strip.

FIG. 9 illustrates an alternate staple 22 a having inwardly curvedbarbed staple ends 52 a. Because the staple ends 52 a are themselvescurved, the corresponding staple bending feature or features 16 a neednot be curved to bend the ends 52 a of the staples 22 a. As shown inFIG. 9, the staple bending features 16 a on each side of the anvil arm14 a may be formed as a single longitudinal groove along the anvil arm14 a, where the staple bending feature 16 a has a substantially flatsurface. When the curved ends 52 a of the staple 22 a are received inthe groove 16 a of the anvil arm 14 a, the ends bend inward to securethe tissue with the staple. Alternately, the staple may be configureddifferently. Alternately, two or more different kinds of staples aredeployed by the staple holder 38 in order to form a single anastomosis.

Referring also to FIG. 10A, a plurality of staples 22 a are positionedon an expandable staple holding strip called an expandable backbone 66.The expandable backbone 66 includes a plurality of elements 68 which areinterconnected by one or more expanding members 70. Each of the backboneelements 68 is provided with a connecting diamond member 72 that isconnected to one of the staples 22 a. As shown in FIG. 10A, each staple22 a is connected to the corresponding diamond member 72 by a thinconnecting section 74. The expandable backbone 66 allows the spacingbetween the staples 22 a to be adjusted for the particular anastomosisto be performed. The backbone 66 allows expansion of the distancebetween staples from a distance of approximately 0.1 mm to a distance ofapproximately 1 to 4 mm, i.e., expansion of up to 40 times the originalspacing. Alternately, the backbone 66 allows a different amount ofexpansion. The expanding backbone 66 also includes two openings 76 atopposite ends which may be engaged by holding pins (not shown) on ananastomosis system or staple holder. The opening 76 allow the backbone66 to be easily expanded by relative motion of the holding pins. Theconnecting diamond members 72 are configured to collapse inwardly towardthe backbone when the staples 22 a engage the staple bending surface orsurfaces 16 a of the anvil. The collapsing of each diamond member 72forces the corresponding staple 22 a to separate from the diamond member72 at a connecting section 74. The connecting section 74 is a frangiblelinkage connecting a staple 22 a to a corresponding diamond member 72.

FIG. 10B illustrates another example of staples 22 a detachablyconnected to a backbone 66. The staples 22 a are each connected to theassociated backbone elements 68 at two connecting sections 74. Thestaples 22 a, backbone 66, and associated components are substantiallyas described above with regard to FIG. 10A.

FIG. 11 shows a portion of an anvil arm 14 with a movable cutting device44. The cutting device 44 includes a base 46 and a blade 48. The base 46of the cutting device 44 is positioned in a longitudinal groove 50 inthe anvil arm 14. After the anvil arm 14 has been inserted into thetarget vessel, the cutting device 44 may be moved longitudinally alongthe anvil arm 14 to form an incision in the target vessel.

FIGS. 12, 12A, and 12B illustrate external cutting devices that areadvanced down onto the anvil arm 14 after the anastomosis procedure andcut an incision in the target vessel from an exterior of the targetvessel as the anvil arm 14 is withdrawn. As shown in FIG. 12, a knife 62is positioned on a knife arm 64 that is movable along the handle 12 ofthe anvil. The knife 62 is moved downward in a direction substantiallyparallel to the longitudinal axis of the handle 12 until the knife 62engages a recess 65 in the anvil arm 14. The knife 62 is therebypositioned substantially at the anastomosis site. The end of the graftvessel is then placed substantially against the wall of the targetvessel at the anastomosis site, over the knife 62 and knife arm 64. Asthe anvil arm 14 is withdrawn from the anastomosis site, the knife 62forms an incision in the target vessel. The knife 62 and knife arm 64exit the anastomosis site via the joint between the graft vessel and thetarget vessel. The withdrawal of the anvil arm 14, knife 62 and knifearm 64 leaves a gap in the wall of the target vessel that isapproximately the same as the spacing between adjacent staples tominimize or eliminate leakage through that gap. Alternately, the knife62 may be moveable relative to the handle 12 in at least one directionin addition to a direction substantially parallel to the longitudinalaxis of the handle 12. For example, the knife 62 may be moveable in adirection substantially parallel to the wall of the target vessel tocreate an arteriotomy in the target vessel at the junction between thegraft vessel and the target vessel.

FIGS. 12A and 12B illustrate two alternate examples of the knife 62which snap onto a corresponding engagement surface 65 of the anvil arm14 so that the knife and anvil are secured together for formation of theincision during removal of the anvil arm 14 from the anastomosis site.

FIGS. 13-16 illustrate two variations of extendable cutting devices formaking an incision in the target vessel while withdrawing the anvil arm14 from the target vessel. FIG. 13 illustrates an anvil arm 14 b havinga blade 78 connected to a flexible blade support 80. When the bladesupport 80 is pulled in the direction of the arrow A with respect to theanvil arm 14 b, the blade 78 moves from a forwardly extending positionshown in FIG. 13 to an upwardly extending position shown in FIG. 14 as aresult of flexure of the blade support 80. The blade 78 in the forwardlyextending position may be used to form a small opening in the wall ofthe target vessel through which the anvil arm 14 is inserted into thetarget vessel. After an anastomosis has been performed, or while ananastomosis is performed, the blade 78 is moved to an upwardly angled ora vertical position in which the blade 78 is used to form an incision inthe target vessel as the anvil arm 14 b is removed from the targetvessel.

FIGS. 15-16 illustrate an alternate example of an anvil arm 14 c havinga blade 84 and a blade support 86. While the anvil arm 14 c is insertedinto the target vessel and during the anastomosis procedure, the blade84 is positioned in a recess 88 in the anvil arm. The blade 84 may bemoved from the position of FIG. 15 to the extended position of FIG. 16by moving the blade support 86 in the direction of the arrow B withrespect to the anvil arm. The blade 84 is flexible and stressed, suchthat freeing the blade 84 from the recess 88 causes the blade 84 to moveto the extended position. Alternatively, the blade 84 may be extendedautomatically upon withdrawal of the anvil arm 14 when a blade tip 90catches on an interior surface of the target vessel wall duringwithdrawal of the anvil arm.

The extendable cutting devices shown in FIGS. 13-16 are merely shown asexamples of the type of cutting devices which may be used for making theincision. Once these cutting devices or blades have been extended fromthe anvil arm, they may be fixed to perform cutting as the anvil arm isremoved from the target vessel or the blades may be movable along theanvil arm to make an incision prior to removal of the anvil arm from thetarget vessel.

Referring to FIG. 55, an exemplary anastomosis tool 300 is shown. Theanastomosis tool 300 includes a handle 302, a shaft 304 connected to thehandle 302, a cable housing 306 connected at one end to the handle 302,and a tissue effector 400 connected to both the shaft 304 and the cablehousing 306. The anastomosis tool 300 may be configured differently, ifdesired. For example, the cable housing 306 may be omitted, and thecable or cables (not shown) that would otherwise extend therethrough areinstead routed through the shaft 304. The handle 302 and/or the tissueeffector 400 may be detachable from the shaft 304 to allow forinterchangeability of these components. In this way, the same handle 302may be used to perform more than one anastomosis within a singlepatient, where a different tissue effector 400 may be connected to thathandle 302 for each anastomosis. Further, the handle 302 may beconstructed from materials that can be sterilized, such as by anautoclave, and reused. The handle 302 may assume any appropriateconfiguration; the shape and configuration of the handle 302 describedherein is exemplary and not limiting. The shaft 304 may be a rigidhollow structure such as a tube of stainless steel, but may be shapeddifferently and/or fabricated from a different material. Further, theshaft 304 may be flexible at least in part, rather than rigid.Alternately, the shaft 304 may be omitted altogether, such that thehandle 302 is connected to the tissue effector 400 by one or more cablesthat would otherwise have extended through the shaft 304. The handle 302includes a trigger 308 that provides for actuation of the anastomosistool 300 based solely on a single input to that trigger 308, asdescribed in greater detail below. Alternately, additional inputs may beutilized to actuate the anastomosis tool 300. For example, actuation ofthe anastomosis tool 300 may be based on an input to one or more buttonsin addition to the trigger 308.

The tissue effector 400 includes an anvil 10 and a staple holder 38. Thetissue effector 400 may be permanently fixed to the shaft 304, or may bedetachable from it such that is it decoupled from the handle 302. Thatis, tissue effectors 400 may be interchangeable. Alternately, the shaft304 is not provided, and the tissue effector 400 is directly coupled tothe handle 302. One end of the cable housing 306 is fixed to the stapleholder 38.

The anvil 10 of the tissue effector 400 may be as described above, ormay be configured differently. Advantageously, the anvil 10 alsoincludes a cutter 200 that is moveable relative to the anvil 10 formaking an incision in the wall of a target vessel. Referring to FIGS. 34and 35, a tissue stop 220 is formed into or connected to the anvil 10.The portion of the anvil 10 distal to the tissue stop 220 is configuredto penetrate into the wall of a target vessel, and may be referred to asthe anvil arm 14. A channel 246 is defined within the anvil arm 14,through which a cutter 200 is configured to move. The cutter 200 isnarrower than the channel 246, such that interior surfaces 202 on eitherside of the channel 246 may guide the translation of the cutter 200relative to the anvil arm 14. As used in this document, the term“translation” as used in regard to the cutter 200 refers to motion ofthe cutter 200 in the distal or proximal direction, whether or not thecutter 200 or a portion thereof moves upward or downward during thatmotion. For convenience, the direction substantially perpendicular tothe longitudinal centerline of the anvil arm 14 toward the wall of thetarget vessel may be referred to as “upward”, and the directionsubstantially perpendicular to the longitudinal centerline of the anvilarm 14 away from the wall of the target vessel may be referred to as“downward”. However, the positioning of the anvil arm 14 in use is notlimited to an orientation in which these directions correspond toabsolute directions measured relative to the ground. Similarly, forconvenience, motion upward or downward may be referred to as “vertical”motion, and motion substantially parallel to the longitudinal centerlineof the anvil arm 14 may be referred to as “horizontal” motion.

The anvil arm 14 includes a contact surface 206. Referring also to FIG.36, in use, the contact surface 206 of the anvil arm 14 is placedsubstantially against the inner surface 203 of a target vessel 201. Thecontact surface 206 substantially defines a place that is substantiallyparallel to the longitudinal centerline of the anvil arm 14.Alternately, the contact surface 206 is contoured and/or orienteddifferently. An upper opening 248 extends along at least a portion ofthe contact surface 206 in a direction substantially parallel to thelongitudinal centerline of the anvil arm 14, and opens into the channel246. The upper opening 248 may divide the contact surface 206 intosymmetrical or asymmetrical sections. Further, the contact surface 206may be formed by two substantially planar surfaces, by one substantiallyplanar surface and a differently-shaped surface, or by another set ofsurfaces. Additionally, the contact surface 206 may be formed by twothin edges, each edge occurring at the intersection of a wall of theupper opening 248 and an outer surface of the anvil arm 14. The upperopening 248 need not extend proximally any further than the tissue stop220. However, the upper opening 248 may extend proximal to the tissuestop 220, if desired. A first lower opening 254 and a second loweropening 268 are defined through a lower surface 256 of the anvil arm 14.The lower surface 256 of the anvil arm 14 may be substantially parallelto the contact surface 206 or may be oriented differently relative tothe contact surface 206. Alternately, the first lower opening 254 and/orthe second lower opening 268 do not extend completely through the anvilarm 14, and instead are depressions extending along at least part of abottom surface 266 of the channel 246.

Referring also to FIGS. 37-38, the cutter 200 is a thin, rigid member,shaped such that it can be held within the channel 246 in the anvil arm14. The cutter 200 has a substantially constant width along its entirelength. Alternately, the width of the cutter 20 may vary along itslength. The cutter 200 may be made of metal, ceramic, plastic, or othermaterial, or from a combination of different materials. A sharpprojection 208 extends upward from the cutter 200 at or near its distalend. The projection 208 is substantially triangular, but may be shapeddifferently. The projection 208 may be smooth or serrated, or otherwiseshaped or formed. A portion of the projection 208 may be ground orotherwise honed to a sharp edge to facilitate the motion of theprojection 208 through the tissue of the wall of a target vessel, asdescribed in greater detail below. If so, the cutter 200 is composed ofa material that can be sharpened adequately to cut tissue. Alternately,the cutter 200 may be flexible, at least in part. Further, theprojection 208 may be located at a different position on the cutter 200than at or near its distal end. An additional sharp point (not shown)may be provided at the distal end of the cutter 200, extending in adistal direction, in order to create an initial puncture or incision inthe wall of the target vessel. Such a point may be as described in U.S.patent application Ser. No. 10/134,081, which is herein incorporated byreference in its entirety.

One or more additional projections 208 may be provided, if desired. Forexample, two or more projections 208 may extend upward from the cutter200. Where multiple projections 208 are used, they may cooperate withone another to create an incision in the wall of the target vessel.Referring also to FIG. 39, a second projection 208 extends upward fromthe cutter 200 proximal to a first projection 208. The projections 208are both substantially the same triangular shape and the same size.However, the projections 208 may be shaped and sized differently. Theprojections 208 are both substantially planar, and are aligned such thatboth projections 208 lie in substantially the same plane. Eachprojection 208 may include at least one sharpened or beveled edge 209oriented to engage and incise the wall of the target vessel when thecutter 200 is translated, as described below. Referring to FIG. 40, atleast two projections 208 extend upward from the cutter 200. Theprojections 208 each have a barb 211 at the tip. However, the barb 211may be omitted from some or all of the projections 208. Under the barb211, a sharpened or beveled edge 209 extends downward and proximally.The edge 209 may be straight or curved. The upper end of the edge 209 isdistal to the lower, proximal end of the corresponding barb. The edge209 of each projection 208 is oriented to engage and incise the wall ofthe target vessel when the cutter 200 is translated. Referring to FIG.41, at least two projections 208 extend upward from the cutter 200, atleast one of which has a barb 211 at its tip. The edge 209 associatedwith each projection 208 is more curved than the edge 209 shown in FIG.40. Alternately, the edge 209 is substantially straight, or gentlycurved, or positioned on a portion of a larger curved segment 213extending downward from and proximal to the barb 211. Referring to FIG.42, a number of projections 208 may be placed along a length of thecutter 200. This length may be comparable to the desired length of theincision in the wall of the target vessel. These projections 208 may besubstantially triangular as shown, or may be shaped differently. Wheremore than one projection 208 is used on the cutter 200, the projections208 need not have the same configuration. For example, projections 208such as the exemplary projections 208 shown in FIGS. 39-41 may be mixedtogether on the same cutter 200. Alternately, one or more of theprojections 208 are moveable relative to the cutter 200, such that oneor more projections 208 can be moved upward or downward relative to thecutter 200.

As another example of a configuration of the projections 208, referringto FIG. 43, the projections 208 extending upward from the cutter 200each are substantially planar, and are aligned such that not all of theprojections 208 lie in the same plane. In such a configuration, theprojections 208 may create a wider incision in the wall of the targetvessel than would be created if the projections 208 were substantiallyaligned. For example, one set of projections 208 may be alignedsubstantially in a first plane, and a second set of projections 208 maybe aligned substantially in a second plane substantially parallel to thefirst plane. The second plane and the first plane may be orienteddifferently relative to one another, if desired. As another example,none of the projections 208 lie in a common plane with one or more otherprojections 208. Referring to FIGS. 39-42, by using multipleprojections, the cutter 200 need not be translated as far to make anincision in the wall of the target vessel as it would if only a singleprojection 208 were used, as described in greater detail below.

Referring back to FIGS. 34-35, an interior surface 202 is located oneach side of the channel 246. Each interior surface 202 may besubstantially planar, curved, or may be shaped differently. Further,each interior surface 202 may be oriented at an angle to vertical orsubstantially vertical. The interior surfaces 202 may be formed suchthat the channel 246 is substantially bilaterally symmetrical, or may beformed to result in a channel 246 that is not bilaterally symmetrical.The interior surfaces 202 of the channel 246 within the anvil arm 14 mayinclude raised features 204 that correspond to depressed staple bendingfeatures (not shown) on the outer surface of the anvil arm 14. That is,if the staple bending features are stamped into the anvil arm 14, orformed in another way that causes deformation of the anvil arm 14, thedepressed staple bending features result in corresponding raisedfeatures 204 on the interior surface 202 of the channel 246. The raisedfeatures 204 do not interfere with the motion of the cutter 200 throughthe channel 246. Alternately, the raised features 204 are not present onthe interior surface 202 of the channel 246.

Optionally, a safety feature 210 may be connected to the underside ofthe anvil 10. The safety feature 210 is biased toward the anvil 10 andthe cutter 200. The safety feature 210 may be biased into the channel246 within the anvil 10. Alternately, the safety feature 210 isconnected to a different location, such as the underside of the anvilarm 14. The safety feature 210 may be flexible or rigid. The safetyfeature 210 includes a tip 212 that is oriented substantially transverseto the longitudinal centerline of the cutter 200. Alternately, the tip212 may be oriented in a different direction. If the safety feature 210is provided, the cutter 200 may include a safety recess 214 defined init, corresponding to the tip 212 of the safety feature 210. The tip 212is shaped and sized such that it can engage the safety recess 214. Thetip 212 may be a bar or rod oriented substantially transverse to thedirection of translation of the cutter 200, or may be shaped or orienteddifferently.

In FIG. 34, the staple holder 38 has not yet been moved into position toperform anastomosis. In this position, if the safety feature 210 isprovided, the tip 212 of the safety feature 210 is biased upward toengage the safety recess 214. The engagement between the safety recess214 and the tip 212 of the safety feature 210 substantially preventstranslation of the cutter 200 within the channel 246. Thus, the cutter200 and the projection 208 are prevented from deploying until the stapleholder 38 has been moved into the appropriate position relative to theanvil arm 14, and inadvertent deployment of the cutter 200 is prevented.

The cutter 200 includes an engagement member 216 extending upward from alocation at or near its proximal end. The engagement member 216 insteadmay extend downward from the cutter 200 or to the side of the cutter200. Further, the engagement member 216 may be positioned at a locationother than at or near the proximal end of the cutter 200. The engagementmember 216 is configured to engage at least a portion of a correspondingreceiver 218 in the staple holder 38. Thus, after engagement between theengagement member 216 and the receiver 218, translation of the receiver218 results in translation of the cutter 200. The receiver 218 is astructure that is at least partially open on its underside and thatincludes at least one surface 219 configured to engage the engagementmember 216. As shown in FIG. 34, the surface 219 is a partially-curvedsurface shaped to receive the curved upper end of the engagement member216. However, the receiver 218 may be a flat vertical surface, a curvedsurface, a structure such as an inverted cup that is open on itsunderside and that has a wall or walls encircling the engagement member216, or any other structure or mechanism capable of engaging theengagement member 216 and urging it distally. Referring also to FIGS. 58and 68-69, the receiver 218 may be defined in a sled 482, which isdescribed in greater detail below.

An anvil insert 222 is fixed to the anvil 10. As one example, the anvil10 is wider proximal to the anvil arm 14, open at its top with a spacetherein. The anvil insert 222 can be inserted into the anvil 10 throughits top, such that the anvil insert 222 is partially or completelypositioned within the anvil 10. However, the anvil insert 222 may beconnected to the anvil 10 in another way. Alternately, the anvil insert222 is connected to and capable of motion relative to the anvil 10.Further, the anvil insert 222 instead may be connected to the proximalend of the anvil arm 14, or another location on the anvil arm 14. Acavity 228 is defined within the anvil insert 222. An aperture 230 isdefined through the distal end of the anvil insert 222 into the cavity228, connecting the channel 246 in the anvil arm 14 and anvil 10 to thecavity 228. The cutter 200 extends through the aperture 230, such thatthe distal end of the cutter 200 is positioned within the channel 246and the proximal end of the cutter 200 is positioned within the cavity228.

A cutter stop 236 may be formed into or connected to the anvil insert222, or formed into or connected to the anvil 10 itself or anotherstructure or mechanism. The cutter stop 236 may engage the proximal endof the cutter 200 if the cutter 200 is moved to a defined positionwithin the cavity 228, thereby restricting its proximal translation. Acavity 262 may be defined within the staple holder 38 or a separatecomponent connected to the staple holder 38. A post 258 is positioned atthe upper end of the cavity 262, where the post 258 is orienteddownward. A biasing element 260 is connected at one end to the post 258.The biasing element 260 may be a coil spring, a leaf spring, a differenttype of spring, an elastomer, a wire form, or other structure ormechanism capable of exerting a biasing force. The biasing element 260is positioned within and protected by the cavity 262, where the cavity262 is used. The cavity 262 may be a cylindrical opening having adiameter substantially the same as the outer diameter of the biasingelement 260, such that the cavity 262 restricts the biasing element 260to motion substantially along the axis of the cavity 262 and thusdirects the force exerted by the biasing element 260 in a substantiallydownward direction, preventing bending or other undesirable motion ofthe biasing element 260. The end of the biasing element 260 that is notconnected to the post 258 contacts the cutter 200. As an example, thebiasing element 260 may be a compression spring that is compressedbetween the post 258 and the cutter 200, resulting in a force on thecutter 200 that biases the cutter 200 downward. The cutter 200 isslidable relative to the biasing element 260, such that the biasingelement 260 exerts a downward force on the cutter 200 at differentlocations along its upper surface 252 as the cutter 200 translates.Thus, at least the distal end of the cutter 200 is biased downwardthroughout its translation along the anvil 10. The entire cutter 200 maybe biased downward, if desired. Alternately, the post 258 is omitted,and the biasing element 260 is fixed to an upper surface of the cavity260. Alternately, the biasing element 260 is omitted, and the cutter 200is biased downward in another way. For example, the cutter 200 may beconstructed from an elastic or superelastic material that is formed insuch a way as to produce a downward bias.

Referring also to FIG. 56, the anvil 10 may include one or moreattachment features 270. The attachment features 270 provide a locationfor attachment of one or more cables or other force transmissionstructures or mechanisms. As one example, the attachment features 270may be one or more passages 270 through the cutter stop 236. The cutterstop 236 may include two or more spaced-apart members. If so, theattachment features 270 may be substantially aligned with one another,or offset from one another. However, the cutter stop 236 may be a singlemember, if desired. As another example, one or more of the attachmentfeatures 270 are separate from the cutter stop 236, and are positionedat a different location on the anvil 10. As another example, one or moreof the attachment features 270 may extend in a direction from the anvil10 that is other than upward.

The configuration of the attachment features 270 is related to theconfiguration of the cable or other force transmission structure ormechanism attached to it, such that the connection between them issecure. As one example, the cutter stop 236 includes two spaced-apartmembers, and the attachment features 270 are passages through the upperportion of each member of the cutter stop 236. Two separate cables areconnected to the attachment features 270. The end of each cable ispassed through one of the attachment features 270, after which it iswelded, connected with adhesive, clamped, tied or otherwise secured tothe cutter stop 236. Alternately, a single first cable is passed througheach of the attachment features 270, such that the free ends of thefirst cable are spaced apart from the attachment features 270. In thisway, no additional steps are needed to secure the first cable to theattachment features 270. However, the cable may be welded, connectedwith adhesive, clamped, tied or otherwise secured to the cutter stop236, if desired.

Referring also to FIG. 44, the anvil 10 extends proximally to a pivotpoint such as a pin 226. The pivot point may be any other structure ormechanism that allows the anvil 10 to rotate about it. Alternately, theanvil insert 222 extends to the pin 226 instead of or in addition to theanvil 10. The pin 226 pivotally connects the staple holder 38 to theanvil 10. The pin 226 may be formed into or otherwise fixed to thestaple holder 38 or anvil 10, if desired. The anvil 10 and/or anvilinsert 222 may extend still further proximally from the pin 226. As oneexample, the anvil 10 extends proximally to the pin 226. The anvilinsert 222 also extends proximally to the pin 226, and additionallyextends as far as or further proximally to the proximal end of the anvil10.

Referring also to FIG. 57, a proximal portion of the anvil insert 222may be bent upward relative to a distal portion of the anvil insert 222.The proximal portion of the anvil insert 222 may be referred to as thespine 272. The spine 272 need not be bent upward relative to theproximal portion of the anvil insert 222, and instead may be bentdownward or oriented substantially parallel to the proximal portion ofthe anvil insert 222. Alternately, the spine 272 is a separate structureor mechanism that is connected to the anvil insert 222. A post 274 maybe defined in or connected to the spine 272. The post 274 may becylindrical, or may be shaped differently. One end of a spring 276 isconnected to the post 274. The spring 276 is a coil spring, but may be adifferent type of spring if desired. The other end of the spring 276 isconnected to the staple holder 38, such as to an attachment member 275defined in or connected to the staple holder 38. The attachment member275 may be cylindrical, or may be shaped differently. The spring 276 maybe connected to the post 274 and to the attachment member 275 by hookingan end of the spring 276 to each, by welding, by adhesive, or by anyother appropriate structure, mechanism or method. The spring 276 may beconnected to the staple holder 38 and/or the spine 272 in a differentway, if desired. The spring 276 is sized and configured to be intension, so as to bias the tissue effector 400 to an open position. Thatis, the spring 276 presses the staple holder 38 about the pin 226,toward the spine 272 of the anvil insert 222.

Optionally, one or more buttons 278 are connected to the spine 272. Thewing or buttons 278 may be spaced apart from the spine 272 and connectedto it by one or more connection members 280. The buttons 278 each may besized and shaped for contact with a user's finger. For example, twobuttons 278 may be sized and shaped such that a user may convenientlypress one with a thumb and the other with a forefinger. The preciseshape and size of the buttons 278 is not critical to the invention.Optionally, at least one button 278 is connected to a cog 282 that inturn connects to the shaft 304 of the anastomosis tool 300, as describedin greater detail below. The cog 282 includes one or more teeth 284.Advantageously, the cog 282 is substantially circular, and the teeth 284extend substantially radially outward from it.

Referring to FIG. 58, the underside of the staple holder 38 is seen. Thestaple holder 38 includes two arms 402, where those arms 402 are spacedapart from one another at least at one end. More or fewer arms 402 maybe provided. The arms 402 extend distally from the remainder of thestaple holder 38. However, the arms 402 may be positioned differently,if desired. The arms 402 are generally linear in configuration, and thelongitudinal centerlines of the arms 402 are substantially parallel toone another. However, the arms 402 may be shaped differently and/ororiented differently relative to one another. One or more of the arms402 may be angled relative to a horizontal plane to facilitateconnecting the flaps of the graft vessel to the wall of the targetvessel. Referring also to FIG. 59, the arms 402 are spaced apart fromone another at least at one end to allow a graft vessel 404 to be placedbetween them, and to allow the tissue effector 400 to be freed from thecompleted anastomosis.

The underside of each arm 402 includes a flap receiving surface 406.Each flap receiving surface 406 is substantially flat across at least aportion of its area. Each flap 408 at the end of the graft vessel 404 isplaced onto a corresponding flap receiving surface 406, and the mainbody of the graft vessel 404 extends between the arms 402 of the stapleholder 38. Advantageously, each flap 408 is substantially flat againstthe corresponding flap receiving surface 406. One or more of the flapreceiving surfaces 406 may include a ridged region 413 that hasindividual ridges 416 spaced apart from one another. The individualridges 416 may be parallel to one another, or oriented differently. Theridges 416 extend away from the flap receiving surface 406. As oneexample, each flap receiving surface 406 includes a ridged region 413 inproximity to its inner edge. As used in this document in the context ofthe staple holder 38, the term “inner” refers to proximity to the spacebetween the arms 402, and the term “outer” refers to distance from thespace between the arms 402.

Advantageously, two flaps 408 are present at the end of the graft vessel404. These flaps 408 may be created in any appropriate manner, such asby incising the end of the graft vessel 404 with a scalpel. However, theend of the graft vessel 404 may have more than two flaps 408. Further,the end of the graft vessel 404 may have a single flap 408. That is, asingle incision may be made at the end of the graft vessel 404,substantially parallel to its centerline. As a result, a single flap 408is created that extends substantially continuously around thecircumference of the end of the graft vessel 404, where the oppositeends of the flap 408 are adjacent to the incision.

Optionally, one or more spikes 410 may extend outward from at least oneof the flap receiving surfaces 406. As at least one of the flaps 408 isplaced onto the corresponding flap receiving surface 406, one or more ofthe spikes 410 penetrate that flap 408 partially or completely, therebyassisting in holding the flap 408 in place against the flap receivingsurface 406.

A graft clip 412 is connected to each arm 402. Each graft clip 412 maybe configured to rotate relative to the corresponding arm 402. As oneexample, each graft clip 412 is pivotally connected to the correspondingarm 402 at or near the outer edge 414 of that arm 402. Alternately, atleast one graft clip 412 is movable relative to the corresponding arm402 in a different way, such as by sliding. Alternately, at least onegraft clip 412 is initially a separate component from the arm 402, andis connectable to the corresponding arm 402. Each graft clip 412 ismoveable between an open position and a closed position relative to thecorresponding arm 402. The graft clip 412 is positioned relative to theflap receiving surface 406 on the corresponding arm 402 such that, inthe closed position, the graft clip 412 is configured to engage a flap408 of the graft vessel 404. The graft clip 412 may engage substantiallyall of the flap 408, or less than all of the flap 408. Optionally, thegraft clip 412 may include ridges 416 corresponding to ridges 416extending from the flap receiving surface 406.

Alternately, the spikes 410 alone hold the flaps 408 onto thecorresponding flap receiving surfaces 406, and one or more graft clips412 are not used. The spikes 410 are oriented at an angle thatfacilitates the opening of the tissue effector 400 after the flaps 408are connected to the target vessel. Where the spikes 410 alone hold theflaps 408, the vein knives 432 that are described below may be omitted,because the staple holder 38 is disengaged from the flaps 408 simply byremoval of the spikes 410 from the flaps 408. Thus, by eliminating thegraft clips 412, construction of the tissue effector 400 may besimplified. Alternately, a structure or mechanism other than or inaddition to the spikes 410 may be used to hold the flaps 408 onto thecorresponding flap receiving surfaces 406.

Each graft clip 412 is locked or otherwise held in the closed positionto securely hold the flap 408 between itself and the corresponding flapreceiving surface 406. The pressure between the graft clip 412 and theflap receiving surface 406, alone or in conjunction with ridges 416 onthe graft clip 412 and the flap receiving surface 406 and/or spikes 410extending upward from the flap receiving surface, holds the flap 408firmly in place. The spikes 410, if used, may engage the graft clip 412when it is in the closed position. The ridges 416 on the graft clip 412and the flap receiving surface 406, if used, engage opposite sides of atleast one flap 408, thereby gripping the flap 408 firmly and resistingmotion of the flap 408 in a direction substantially perpendicular to theorientation of the ridges 416. However, each graft clip 412 may beshaped or configured in any manner that allows it to participate inholding the corresponding flap 408 to the corresponding flap receivingsurface 406.

The graft clip 412 may be locked or otherwise held in the closedposition with any appropriate mechanism, structure or method. As oneexample, the graft clip 412 uses a cam lock to hold itself in the closedposition. Referring also to FIG. 59A, the graft clip 412 is in an openposition. In the open position, the graft clip 412 is positioned toreceive a flap 408 of the graft vessel 404 between it and the flapreceiving surface 406. The graft clip 412 is rotatable about an axle 418that is spaced apart from a wall 420 defined on an arm 402 of the stapleholder 38. The wall 420 may be perpendicular or otherwise angled to theflap receiving surface 406. The axle 418 is connected to the arm 402,and is substantially fixed relative to the wall 420. Alternately, theaxle 418 is movable relative to the wall 420. The axle 418 extendssubstantially longitudinally, but may be angled relative to thelongitudinal direction. The arm 402 also includes an overhang 586 thatextends outward and downward from the main portion of the arm 402.Alternately, the overhang 586 extends in a different direction. Theoverhang 586 may extend laterally outward at least as far as thelongitudinal centerline of the axle 418, but need not do so.

The graft clip 412 includes a lobe 422 in proximity to the axle 418,where the lobe 422 has a non-circular cross section. The lobe 422 has avariable thickness, where thickness is defined as the distance betweenthe surface of the axle 418 and the surface of the lobe 422. The lobe422 includes a first portion 588 that has a relatively small thickness.When the graft clip 412 is in the open position, the first portion 588is substantially adjacent to the overhang 586. The thickness of thefirst portion 588 of the lobe 422 is substantially equal to the distancebetween the axle 418 and the overhang 586. Alternately, the firstportion 588 of the lobe 422 may have a different thickness. Movingcounterclockwise along the lobe 422, its thickness increases, thendecreases rapidly to form a step 590, which may be substantially alignedwith the centerline of the axle 418. Continuing to move counterclockwisealong the lobe 422, its thickness once again increases. The graft clip412 may be a mirror image of the clip 412 shown in FIG. 59A, such thatthe thickness of the lobe 422 relative to the angular position thereonis reversed from the description above. Similarly, if the graft clip 412is viewed from the opposite direction, the thickness of the lobe 422will be reversed from the description above. The operation of the graftclip 412 is the same.

In the open position, which is the initial position of the graft clip412, the first portion 588 of the lobe 422 is adjacent to the overhang586. This first portion 588 may be substantially as thick as thedistance between the axle 418 and the overhang 586. The portion of thelobe 422 adjacent to and immediately clockwise from the step 590 may bein contact with or in proximity to the wall 420. The graft clip 412 isrotated about the axle 418 from the open position to the closed positionin a clockwise direction by the user or by a mechanism associated withthe tissue effector 400. As this rotation begins, increasingly-thickportions of the lobe 422 move between the axle 418 and the overhang 586.As a result, the overhang 586, axle 418, and/or lobe 422 may flex toaccommodate the increased amount of thickness of the lobe 422 betweenthe axle 418 and the overhang 586. Further, this increase in thicknessbetween the axle 418 and the overhand 586 may provide at least someresistance to the motion of the graft clip 412.

Referring also to FIG. 60, as the rotation of the graft clip 412continues, the step 590 encounters the overhang 586, then moves past theoverhang 586. As a result, the thickness of the lobe 422 between theoverhang 586 and the axle 418 decreases abruptly. The stiffness of theoverhang 586 is such that the overhang 586 can flex enough to allow thegraft clip 412 to rotate past the step 590. Rotation of the graft clip412 may stop at or shortly after the motion of the step 590 past theoverhang 586, such that the graft clip 412 stops at the closed positionshown in FIG. 59C. Motion of the graft clip 412 in the counterclockwisedirection would cause the step 590 to encounter the end of the overhang586, stopping the rotation of the graft clip 412. Thus, the step 590acts to hold the graft clip 412 in the closed position.

Alternately, a structure or mechanism other than a cam lock may be usedto hold the graft clip 412 in a closed position. As one example, atleast one elastic band (not shown) may be used to hold the graft clip412 against the staple holder 38. Each elastic band may be fixed toeither the graft clip 412 or the staple holder 38. As another example,the graft clip 412 and the corresponding arm 402 may each includecorresponding magnets (not shown), such that magnetic force holds thegraft clip 412 in contact with the arm 402 in the closed position.

As another example, referring to FIG. 60, a snap arm 606 may be used tohold the graft clip 412 in a closed position. The snap arm 606 isconnected at one end to the corresponding arm 402. This connection maybe a hinge, or may be any other connection that allows the snap arm 606to move between an open position, in which the graft clip 412 may beopened, and a closed position, in which the graft clip 412 is heldclosed. The connection between the proximal end of the snap arm 606 andthe arm 402 is made proximal to the flap receiving surface 406.Alternately, the connection between the snap arm 606 and the stapleholder 38 is made at a different location. Alternately, a different partof the snap arm 606 than its proximal end is connected to the arm 402.

The distal end of the snap arm 606 includes a catch 608 that is shapedto engage the distal end of the corresponding arm 402. For example, thecatch 608 may be curved such that a lobe 610 of the catch 608 isproximal to the distal end of the arm 402 when the snap arm 606 is inthe closed position, thereby holding the snap arm 606, and the graftclip 412, in place. The catch 608 is at least partially flexible suchthat the catch 608 can be snapped down onto the distal end of thecorresponding arm, thereby holding the snap arm 606 in the closedposition. The catch 608 may be configured differently, if desired. Whenthe snap arm 606 is in the closed position, at least a portion of thegraft clip 412 is positioned between the snap arm 606 and thecorresponding arm 402. Thus, in the closed position, the snap arm 606presses the graft clip 412 against the arm 402, holding it in place. Asa result, the graft clip 412 holds the corresponding flap 408 againstthe flap receiving surface 406.

Alternately, a separate snap arm 606 is not used, and the graft clip 412itself includes a catch 608 that engages the corresponding arm 402 ofthe tissue effector 400. Alternately, the snap arm 606, or the graftclip 412 that includes a catch 608, is oriented differently, such asdescribed above with regard to FIGS. 59A-59B.

Referring also to FIG. 61, in the closed position, each graft clip 412is configured to press a flap 408 of the target vessel against thecorresponding flap receiving surface 406. The flap 408 is not shown forclarity. In the closed position, the graft clip 412 and the flapreceiving surface 406 are substantially fixed relative to one another.The graft clip 412 and the corresponding flap receiving surface 406 maybe configured such that a portion of each would contact the other in theclosed position, absent the flap 408. Thus, where the flap 408 ispresent, the graft clip 412 compresses the flap 408 against the flapreceiving surface 406. Additionally, the graft clip 412 may include anoverhang 424, which extends along at least a portion of the edge of thegraft clip 412. The overhang 424 may be substantially parallel to and inproximity to the corresponding inner edge 411 of the arm 402 in theclosed position. Alternately, the overhang 424 may be configureddifferently relative to the arm 402. The overhang 402 may bend the flap408 and/or press, pinch or otherwise hold it against the correspondingedge of the arm 402.

Still referring to FIG. 61, a first channel 426 may be defined in thegraft clip 412, and a corresponding second channel 428 may be defined inthe arm 402. The first channel 426 and the second channel 428 aresubstantially linear and substantially aligned with one another.Alternately, the first channel 426 and the second channel 428 areconfigured differently, aligned differently with respect to one anotherand/or have a different cross-section. Each channel 426, 428 is openalong one side, at least in part. The first channel 426 and the secondchannel 428 are oriented and aligned relative to one another such thatthe openings in the channels 426, 428 face one another to form a veinknife passage 430. The channels 426, 428 may be spaced apart from oneanother at least in part and still form the vein knife passage 430; thatis, the vein knife passage 430 need not be bounded around its entireperiphery. Alternately, the channels 426, 428 are oriented and aligneddifferently, and/or the vein knife passage 430 is formed differently.Each vein knife passage 430 is oriented such that, when the tissueeffector 40 is in the closed position, the longitudinal centerline ofthe vein knife passage 430 is substantially parallel to the longitudinalaxis of the anvil 10. Alternately, the vein knife passages 430 arealigned differently relative to the longitudinal axis of the anvil 10when the tissue effector 400 is in the closed position.

Referring also to FIG. 62, at least one vein knife passage 430 isconfigured to receive a corresponding vein knife 432. The fit betweenthe dimensions of the vein knife 432 and the corresponding vein knifepassage 430 is close enough that the vein knife passage 430 guides thevein knife 432 and substantially prevents wobbling or other disruptionof the motion of the vein knife 432 as it travels along the vein knifepassage 430, and loose enough to allow the vein knife 432 to slideeasily along that vein knife passage 430 substantially without bindingor interference. Each vein knife 432 has a blade 434 or other sharpelement at its distal end. The blade 434 of at least one vein knife 432may be angled. Alternately, the blade 434 of at least one vein knife maybe curved or otherwise shaped. The proximal end of each vein knife 432is connected to a sled, which is described in greater detail below. Thevein knife 432 is configured to translate or otherwise move between afirst position and a second position. In the first position, the blade434 of the vein knife 432 is located proximal to the flap 408 heldbetween the graft clip 412 and the flap receiving surface 406. The veinknife 432 translates or otherwise moves to the second position and cutsthe flap 408 as it does so. In the second position, the blade 434 of thevein knife 432 is located adjacent or distal to the portion of the flap408 held between the graft clip 412 and the flap receiving surface 406.The first and second positions are reversed when the vein knife 432 ismoved in the opposite direction.

Optionally, one or more graft clip blades 436 are connected to at leastone graft clip 412. Referring also to FIG. 63, one or more of the graftclip blades 436 may be serrated. Each graft clip blade 436 is located inand against one side of the first channel 426, such that it does notinterfere with the motion of the vein knife 432. Alternately, one ormore graft clip blades 436 are located in a different position on thecorresponding graft clip 412 or arm 402. Serrations 438 on the graftclip blade 436 are oriented toward the open face of the first channel426 in the graft clip 412. The serrations 438 may be sized and shaped inany appropriate manner. The serrations 438 assist in holding the flap408 between the graft clip 412 and the flap receiving surface 406. Thatis, one or more of the serrations 438 may penetrate into or through theflap 408, thereby holding the tissue of the flap 408 substantially fixedrelative to the graft clip 412 and the flap receiving surface 406. Whenthe vein knife 432 translates along the vein knife passage 430 to incisethe flap 408, the serrations 438 hold the flap 408. The motion of thevein knife 432 may apply stress to the tissue of the flap 408 such thatthe serrations 438 themselves act to cut the tissue of the flap 408.Thus, the cutting action may be a scissors-like action resulting fromthe relative motion of the vein knife 432 and the graft clip blade 436.More than one graft clip blade 436 can be provided in at least one veinknife passage 430. For example, two graft clip blades 436 may be locatedin one first channel 426, in and against two different sides of thefirst channel 426 and spaced apart from one another a sufficientdistance to allow the vein knife 432 to slide therebetween. Otherconfigurations or numbers of graft clip blades 436 may be utilized, ifdesired.

Alternately, referring to FIG. 59D, at least one graft clip 412 may havea thinner cross-section than the graft clip 412 of FIGS. 59-59B. Thisthinner cross-section may be achieved by utilizing metal, such as sheetmetal, to form at least part of the graft clip 412. However, metal neednot be used in order for the graft clip 412 to be made thinner. As shownin FIG. 59C, the graft clip 412 may be an assembly having a first piece407 connected to a second piece 409. The first piece 407 is located ator near the first channel 426 of the graft clip 412. Alternately, thegraft clip 412 may be a single-piece, or may be an assembly havingadditional components. The second piece 409 may be made of plastic orany other suitable material. Other materials may be used to form thepieces 407, 409 if desired. Advantageously, the graft clip blades 436may be formed into the first piece 407, particularly where at least thefirst piece 407 of the graft clip 412 is metal. By forming the graftclip blades 436 into a portion of the graft clip 412 rather thanconnecting them to the graft clip 412, construction of the graft clip412 may be simplified.

The use of a thinner graft clip 412 results in less compression of thesurface of the heart, where the target vessel is a coronary artery andthe anvil arm 14 is inserted into that coronary artery. The verticaldistance between the bottom of the anvil arm 14 and the bottom of thegraft clip 412 substantially defines the distance across which the hearttissue near the coronary artery is compressed as the tissue effector 400moves from the open to the closed position. By decreasing that distance,the heart tissue around the coronary artery is compressed a lesserdistance. As a result, the amount of force required to move the tissueeffector 400 from an open position to a closed position, in whichcompressive force is applied against the heart tissue, may be decreased.This reduction in force may simplify the construction of the tissueeffector 400.

Referring also to FIG. 64, a cross-section of one arm 402 of the stapleholder 38 is shown. The staple holder 38 is substantially symmetrical,such that the arm 402 shown is substantially a mirror image of the otherarm 402. Alternately, the staple holder 38 is not symmetrical, and/orthe arms 402 are not mirror images of one another. A passage 440 isdefined within each arm 402. Each passage 440 extends substantiallylongitudinally within the corresponding arm 402, and the longitudinalcenterline of each passage 440 is substantially parallel to thelongitudinal centerline of the anvil 10 when the tissue effector 400 isin the closed position. Alternately, at least one passage 440 isoriented differently relative to its corresponding arm 402. The passage440 may have a rectangular cross-section, or a different cross-section.Further, the dimensions of the passage 440 may be substantially constantalong its entire length, or may change along at least part of itslength. Optionally, the distal end 442 of the passage 440 is open,and/or the proximal end 444 of the passage 440 is open.

A ramp element 446 is configured to translate or otherwise move throughat least a portion of each passage 440. Referring also to FIGS. 68-69A,the ramp elements 446 may be molded or otherwise formed into a unitaryramp element assembly 484, or may be molded or otherwise formedseparately and then connected together. The ramp elements 446 may beformed from stainless steel or other appropriate material. The veinknives 432 are connected to the ramp element assembly 484 to form a sled482. As an example, apertures 486 are defined in the ramp elementassembly 484, and the proximal end of each vein knife 432 is sized andshaped to provide for a pressure or interference fit within thecorresponding aperture 486. However, any other appropriate mechanism,structure or method may be used to connect each vein knife 432 to theramp element assembly 484. Alternately, the ramp elements 446 and thevein knives 432 are cast, molded or otherwise formed as a single unit.The vein knives 432 are fixed to the ramp element assembly 484, suchthat the ramp elements 446 and the vein knives 432 translate as a unitsubstantially simultaneously. Alternately, at least one ramp element 446is moveable relative to at least one vein knife 432. As another exampleof the sled 482, each ramp element 446 is connected to the correspondingvein knife 432, but the ramp elements 446 are not connected to oneanother.

The sled 482 includes an attachment feature 488. The attachment feature488 may be an aperture through a portion of the ramp element assembly484 that is configured to receive a second cable 490 or other forcetransmission mechanism or structure. Where a cable is used and theattachment feature 488 is an aperture, the second cable 490 may beinserted into and/or through the attachment feature 488, and held inplace there such as by tying off one end of the cable, by welding, byadhesive, or any other appropriate connection method. Alternately, theattachment feature 488 may be a ring, a hook, a raised area, adepression, or any other structure or mechanism appropriate forconnection to a cable or other force transmission mechanism orstructure.

One or more connector bays 448 are defined in each arm 402, between thepassage 440 within the arm 402 and an inner surface 450 of the arm 402.The connector bays 448 and the passages 440 are substantially hollow.The cross-sectional shape of each connector bay 448 is selected to allowit to receive and hold a staple, as described below. The connector bays448 are oriented such that the longitudinal centerline of each connectorbay 448 is substantially perpendicular to the longitudinal centerline ofthe corresponding passage 440. Alternately, at least one connector bay448 is oriented differently relative to the corresponding passage 440.Each connector bay 448 has substantially the same cross-section andlength. Alternately, at least one connector bay 448 has a differentcross-section and/or length than at least one other connector bay 448.The connector bays 448 may be oriented relative to a local horizontalsuch that the longitudinal centerline of each connector bay 448 forms anangle of between 0° and 45° relative to that local horizontal. Adifferent orientation may be used, if desired. The use of the term“horizontal” here and elsewhere in this document is used for conveniencein description only, and does not restrict the orientation in which theanastomosis tool 300 may be used.

Referring also to FIG. 65, at least one connector bay 448 is configuredto receive a connector deployer 452. Each connector bay 448 is shaped toallow the corresponding connector deployer 452 to translate or otherwisemove within it. The sliders 452 may be shaped in any appropriate manner.As one example, a connector deployer 452 is substantially curved at itsouter end 454 and substantially flat at its inner end 456. The connectordeployer 452 may vary in height along at least a portion of its lengthand/or width. As one example, a registration element 458 may extendupward from the upper surface 460 of the connector deployer 452. Theregistration element 458 may be formed into the connector deployer 452,or otherwise manufactured into it or connected to it.

Where a registration element 458 is used, the corresponding connectorbay 448 is shaped accordingly. That is, the size, shape and orientationof the registration element 458 of the connector deployer 452corresponds to the size, shape and orientation of a registration feature462 of the connector bay 448. For example, where the connector deployer452 and registration element 458 of FIG. 65 is used, the correspondingconnector bay 448 is shaped as shown in FIG. 66. The registrationelement 458 translates along the registration feature 462 as theconnector deployer 452 translates along the connector bay 448. In thisway, the connector deployer 452 is maintained in a desired orientationthroughout its translation relative to the connector bay 448, and theconnector deployer 452 is prevented from cocking in the connector bay448 during that translation. The sliders 452 and corresponding connectorbays 448 may be shaped differently, if desired. The sliders 452 are allshaped substantially identically. Alternately, at least one of thesliders 452 is shaped differently from at least one of the others, andthe corresponding connector bay or bays 448 are shaped accordingly.Optionally, a biocompatible lubricant such as sodium stearate may beused between at least one connector deployer 452 and the correspondingconnector bay 448 to facilitate the translation of the connectordeployer 452 relative to the connector bay 448.

Each connector deployer 452 is moveable between a first position and asecond position. In the first position, the outer end 454 of theconnector deployer 452 extends at least partially into the passage 440.Alternately, the outer end of the connector deployer 452 does not extendinto the passage 440. In the second position, the connector deployer 452has translated relative to the corresponding connector bay 448 andcompleted its motion. The outer end 454 of the connector deployer 452 nolonger extends into the passage 440. Alternately, the outer end 454 ofthe connector deployer 452 still extends into the passage 440 in thesecond position. Each connector deployer 452 translates or otherwisemoves from the first position to the second position as a result ofcontact with the ramp element 446. This translation is described ingreater detail below.

A connector 464 is placed in at least one connector bay 448. In anexemplary embodiment shown in FIG. 64, the connector 464 is a staple.Each connector 464 is located closer to the inner surface 450 of the arm402 than the corresponding connector deployer 452. The connector 464 maybe configured as disclosed in pending U.S. patent application Ser. No.10/309,519 filed on Dec. 4, 2002, which is hereby incorporated byreference in its entirety. As one example, referring also to FIG. 67,the connector 464 includes four tines 466 extending from a base 468. Thetines 466 may be offset from one another. A different configuration ofconnector 464 may be used, if desired. The connector 464 is constructedfrom 316L stainless steel, but may be constructed from a different typeof stainless steel, or from a different material. As another example,the connector 464 may be a connector other than a staple, such as a pinor clip.

Each connector 464 is oriented in the connector bay 448 such that thetines 466 extend in a direction facing substantially out of theconnector bay 448. Alternately, each connector 464 is orienteddifferently. The base 468 of the connector 464 may be in contact withthe inner end of the corresponding connector deployer 452 when thatconnector deployer 452 is in the first position, or may be spaced apartfrom the inner end of that connector deployer 452 in the first position.When the connector deployer 452 is in the first position, thecorresponding connector 464 is held within the connector bay 448 in anyappropriate way. Referring also to FIG. 66, as one example, the tines466 of each connector 464 may be biased against at least part of thecorresponding connector bay 448. For example, at least one tine 468 maybe biased against a lower surface 470 of the connector bay 448 and atleast one other tine 469 may be biased against an upper surface 472 ofthe connector bay 448.. The biasing force exerted by each tine 468against the corresponding surface 470, 472 of the connector bay 448holds the connector 464 in place when the connector deployer 452 is inthe first position. The biasing forces exerted by the tines 468 are highenough to hold the connector 464 securely within the connector bay 448,and are low enough to allow the connector 464 to translate easily as aresult of contact with the corresponding connector deployer 452. Asanother example, each connector 464 may be held in place in thecorresponding connector bay 448 with a biocompatible substance thatprovides friction between that connector 464 and the connector bay 448,where the amount of force required to overcome that friction and movethe connector 464 is selected to be less than the amount of deploymentforce to be exerted on the connector 464 by the corresponding connectordeployer 452. The translation of a connector deployer 452 from the firstposition to the second position causes deployment of the correspondingconnector 464, as described in greater detail below.

The ramp element 446 translates or otherwise moves within the passage440, as described above. The distal end 474 of the ramp element 446 isconfigured to engage the sliders 452 as it moves, causing those sliders452 in turn to translate or otherwise move relative to their respectiveconnector bays 448. As one example, the ramp element 446 is curvedand/or angled at its distal end 474, where the curvature and/orangularity begins at or near the most distal point of the ramp element446 and continues proximally along the inner surface 476 of the rampelement 446. That is, the ramp element 446 increases in width from itsmost distal point to a selected point spaced apart from and proximal tothat most distal point. The ramp element 446 may be shaped such that thecurvature and/or angularity of the distal end 474 is present on theinner surface 476 of the ramp element 446, and such that the outersurface 478 of the ramp element 446 is substantially flat against a wallof the passage 440. However, the ramp element 446 may be shaped in anyother appropriate manner. The ramp element 446 may be translateddistally along at least a portion of the passage 440. In the course ofthis translation, the distal end 474 of the ramp element 446sequentially contacts and thereby actuates the sliders 452, beginningwith the most proximal and concluding with the most distal. Alternately,the ramp element 446 translates proximally to contact and actuatesequentially the sliders 452, beginning with the most distal andconcluding with the most proximal. Alternately, the ramp element 446 isconfigured to move in such a manner that at least a component of itsmotion is toward the inner surface 450 of the arm 402, such that theramp element 446 engages more than one connector deployer 452 at a time.Thus, the ramp element 446, another component of the sled 482, or adifferent component may actuate the sliders 452 serially or in parallel.

Optionally, one or more of the sliders 452 are omitted from the tissueeffector 400, such that the ramp element 446 and/or a differentcomponent of the sled 482 directly contacts one or more of the staples464 to urge that staple or staples 464 out of the corresponding arm 402.That is, the intermediate mechanism between the sled 482 and at leastone of the staples 464 may be omitted. If so, the sled 482 and/or atleast one connector 464 are configured such that contact between themurges the connector 464 in the desired direction. For example, one ormore of the staples 464 may include a structure analogous to theconnector deployer 452 formed into it, where that structure is implantedinto the patient along with the connector 464. This additional structureis small, and is positioned outside the lumen of both the graft vesseland the target vessel, such that its presence in the patient has noeffect. Such a structure may be composed of stainless steel or otherbiocompatible material, or from bioabsorbable material that is graduallyabsorbed by the patient. Such biocompatible and bioabsorbable materialsare standard in the art.

Optionally, one or more of the connector bays 448 may be omitted fromone or more of the arms 402 of the tissue effector 400. For example, ifthe staples 464 are deployed in parallel, the staples 464 may beconnected to the sled 482 or other component such as by adhesive, wherethat connection is able to withstand an amount of force less than theforce with which the deployed connector 464 grips the graft vessel 404and the target vessel 580. As a result, after the staples 464 aredeployed into tissue and grip the vessels 404, 580 and the sled 482 orother component is pulled away from the anastomosis, the connectionbetween each connector 464 and the sled 482 or other component isbroken, thereby freeing the staples 464 from the tissue effector 400.

Referring also to FIGS. 58 and 74, the anvil 10 is connected to a forcetransmission mechanism such as a first cable 480. As described above,the anvil 10 may include a cutter stop 236 having one or more attachmentfeatures 270 to which the first cable 480 is connected. However, thefirst cable 480 may be connected to a different or an additional part ofthe anvil 10.

The sled 482 is connected to a force transmission mechanism such as asecond cable 490. As described above, the sled 482 includes anattachment feature 488 to which the second cable 490 is connected.However, the second cable 490 may be connected to a different or anadditional part of the sled 482. Alternately, one or both of the cables480, 490 are not used, and a different force transmission mechanism isused instead. For example, one or both force transmission mechanisms maybe a chain, a shaft, one or more gears, one or more tubes for handlingpressurized gas or vacuum, conductive elements for carrying electricity,and/or other appropriate mechanisms.

The cables 480, 490 extend proximally from the tissue effector 400.Optionally, a cable housing 306 is provided. The cable housing 306 is atube that is at least partially flexible, through which at least aportion of the cables 480, 490 extend. Two or more lumens or passagesmay be present in the cable housing 306, such that each cable 480, 490extends through a different lumen or passage. Referring also to FIG. 57,the staple holder 38 includes a collar 492. The collar 492 may be formedinto the staple holder 38, or formed separately from and attached to thestaple holder 38. The collar 492 includes a passage 494 therethrough.The diameter of the passage 494 may be substantially the same as theouter diameter of the cable housing 306, such that the distal end of thecable housing 306 may be received into and/or through the collar 492 andheld therein. Similarly, the shape of the passage 494 may substantiallycorrespond to the shape of the distal end of the cable housing 306. Thedistal end of the cable housing 306 is fixed to the collar 492 via afriction fit, adhesive, welding, or any other appropriate structure,mechanism or method. The cable housing 306 need not have a uniformshape, size or cross-section along its entire length. Alternately, thedistal end of the cable housing 306 may connect to a different portionof the tissue effector 400, or may not connect to the tissue effector400 at all. Additionally, the cable housing 306 may pass over and/orconnect to one or more of the connection members 280 of the tissueeffector 400, and/or one or more other components of the tissue effector400.

One or more channels 496 may be defined on the surface of the stapleholder 38 distal to the collar 492. Each channel 496 receives a cable480, 490. At least one channel 496 may be curved in a convex manner,such that the corresponding cable 480, 490 curves as well. The convexcurvature causes the most distal part of that channel 496 to be locatedbetween the upper and lower ends of the channel 496. The cable 480, 490in that channel 496 may be under tension, such that it follows thecurvature of that channel 496. Thus, the channel 496 causes the cable480, 490 received therein to curve back in a proximal direction. Forexample, the second cable 490 is connected to the sled 482. Tension onthe second cable 490 that results from proximal motion of its proximalend also results in distal motion of the sled 482.

Referring also to FIG. 56, the shaft 304 may be bifurcated at its distalend, forming two spaced-apart arms 305. The cable housing 306 passesbetween the arms 305, such that the arms 305 constrain the potentiallateral motion of the cable housing 306. Alternately, the cable housing306 does not pass between the arms 305. At least one arm 305 forms orconnects to a paddle 307 at its distal end. The cable housing 306extends in a curved configuration, such as an S-shaped or serpentineconfiguration, between the shaft 304 and the tissue effector 400. Thepaddle or paddles 307 may be substantially planar and parallel to oneanother. A receiving opening 309 is provided through at least one paddle307, each opening corresponding to a cog 282 of the tissue effector 400.One or more detents 310 are present along the perimeter of the receivingopening 309, corresponding to the teeth 284 of the cog 282. The teeth284 are configured to engage the detents 310 in the receiving opening309. The button 278 connected to the cog 282 may be connected to thespine 272 with a single connection member 280 spaced apart from the cog282, or may be connected to the spine 272 with one or more flexibleconnection members 280. As a result, the buttons 278 can be compressedtogether, such that the teeth 284 are moved out of engagement with thecorresponding detents 310. The cog 282 thus can be moved to a positionout of contact with the receiving opening 309, such that it is locatedbetween the paddles 307. Consequently, the cog 282 and the tissueeffector 400 can be freely rotated to a desired orientation. The buttons278 are then released, such that the cog 282 re-enters the receivingopening 309 and the teeth 284 engage the detents 310 in the receivingopening 309 once again. Alternately, the cog 282 engages a correspondinggear or other structure or mechanism in or on the shaft 304, such thatmotion of the corresponding gear rotates the cog 282. Alternately, thecog 282 is connected to the shaft 304 or one or more components inand/or on the shaft 304 in such a way that the cog 282 can be rotated orotherwise manipulated as desired. Alternately, the tissue effector 38 isconnected to the shaft 304 with a mechanism or structure other than orin addition to the cog 282.

The cog 282 allows the tissue effector 38 to be oriented at a pluralityof positions relative to the shaft 304. That is, the cog 282 allows thetissue effector 38 to move such that the longitudinal centerline of thetissue effector 38 may be positioned at more than one angle relative tothe longitudinal centerline of the shaft 304. The cog 282 or othermechanism may allow the tissue effector 38 to move smoothly through arange of orientations relative to the handle 302, or may allow thetissue effector 38 to move among two or more discrete orientationsrelative to the handle 302. Thus, the tissue effector 38 is orientableto two or more different positions relative to the handle 302. Therelative motion between the tissue effector 38 and the shaft 304 allowsthe tissue effector 38 to be utilized on target vessels having a numberof different orientations within the patient, while allowing convenientaccess by the surgeon or other medical professional. That is, thesurgeon may hold the handle 302 in a single convenient position, andorient the tissue effector 38 into a selected position relative to theshaft 304 and handle 302 that is optimal for use with a particulartarget vessel. Optionally, the arms 305 or a mechanism connected to thearms may be capable of rotation relative to the shaft 304, providingadditional freedom of motion for the tissue effector 38. Alternately,the cog 282 is not present, and the arms 305 otherwise allow motion ofthe tissue effector 38 relative to the shaft 304. Alternately, thetissue effector 400 is fixed relative to the shaft 304.

Referring also to FIG. 55, the shaft 304 is substantially hollow alongat least part of its length, starting at its proximal end and continuingdistally. The entire shaft 304 may be substantially hollow. An aperture498 or other opening is located in the wall of the shaft 304 at a pointalong its length where it is hollow. Thus, the aperture 498 providesaccess to the lumen of the shaft 304. The cable housing 306 extendsthrough the aperture 498 into the lumen of the shaft 304. Alternately,the cable housing 306 does not enter the lumen of the shaft 304, andinstead is attached to the outer surface of the shaft 304 with adhesive,clips, pins, and/or any other appropriate attachment mechanisms,structures or methods. If so, the shaft 304 need not include a lumen.Alternately, the cable housing 306 does not connect to the shaft 304 atall, and instead connects to the handle 302 directly. If so, the shaft304 need not include a lumen, and may be solid.

The proximal end of the shaft 304 is connected to the handle 302. Thehandle 302 may be formed from two or more individual handle shellmembers 502 that are connected to one another. Alternately, the handle302 may be constructed differently. The shaft 304 may be fixed to thehandle 302 such that it does not substantially move relative to thehandle 302. Referring also to FIG. 70, as one example, a member 500extends from one handle shell member 502 into the hollow interior of thehandle 302. That member 500 may connect at its other end to the otherhandle shell member 502. The proximal end of the shaft 304 includes acorresponding aperture 504, such that the member 500 fits within theaperture 504. The aperture 504 is substantially the same size as thecross-section of the member 500. When the shell members 502 areassembled, the member 500 engages the aperture 504 of the shaft 304 andholds the shaft 304 in place. Alternately, a member 500 extends fromeach handle shell member 502, and those members 500 both engage theaperture 504 of the shaft 304. As another example, ribs (not shown) maybe defined in the inner surface of the handle, and a correspondingretainer (not shown) is defined at or near the proximal end of theshaft. The retainer is wider than the shaft 304, and has a selectedthickness. The ribs are spaced apart from one another substantially thesame distance as the thickness of the retainer. The ribs thussubstantially prevent the shaft 304 from translating proximally ordistally. The handle 302 may engage the retainer with a registrationfeature or other structure or mechanism to substantially preventrotation of the shaft 304 about its longitudinal axis. Alternately, thehandle 302 holds the shaft 304 in a different way.

The handle 302 has a substantially hollow interior. Where the shaft 304includes a lumen, the lumen of the shaft 304 opens into the interior ofthe handle 302. The cables 480, 490 extend out of the lumen of the shaft304 into the hollow interior of the handle 302. Alternately, the cables480, 490 extend through the cable housing 306 directly into the handle302, bypassing the shaft 304.

Referring to FIGS. 70 and 78, mechanisms within the handle 302 areutilized to actuate the tissue effector 38 via the cables 480, 490.Alternately, at least some of those mechanisms are separate from thehandle 302. A single input to the anastomosis tool 300 via the trigger308 actuates the anastomosis tool 300. Alternately, one or moreadditional inputs to the anastomosis tool 300 are required, such asactuation of a safety switch or depression of a second feature. Thetrigger 308 initially extends outward from the upper surface of thehandle 302 through an aperture 506 in the handle 302. Alternately, thetrigger 308 initially extends from a different surface of the handle302. Alternately, the trigger 308 is initially flush with the surface ofthe handle 302, or otherwise configured. The handle 302 may be shapedergonomically for ease of operation. For example, as shown in FIGS. 70and 78, the handle 302 is curved and tapered slightly toward itsproximal end, and substantially bilaterally symmetrical, such that theproximal end of the handle 302 can be gripped easily with either theleft or the right hand. Alternately, the handle 302 may be ergonomicallyconfigured in a different way for ease of actuation by the user. Thetrigger 308 is positioned on the handle 302 such that it can be actuatedconveniently by a user's thumb. Alternately, the trigger 308 could beplaced on the underside of the handle 302 for actuation with the indexfinger of either hand. More than one finger may be used to actuate thetrigger 308 and/or other mechanisms for actuating the anastomosis tool300.

The trigger 308 is connected to a rocker 508. The trigger 308 may beformed into the rocker 508, or otherwise connected to it. The rocker 508is located inside the handle 302. Alternately, the rocker 508 is locatedat least partly outside the handle 302. The rocker 508 is rotatablymounted to a rocker axle 510. The rocker axle 510 extends from oneinterior surface of the handle 302, and may extend to a differentinterior surface of the handle 302 to provide additional stiffnessand/or stability to the rocker axle 510. Alternately, the rocker axle510 may connect to the handle 302 in a different way.

The rocker 508 includes a proximal arm 514 extending proximally to therocker axle 510. The proximal arm 514 may be formed into the rocker 508,or otherwise connected to it. The proximal end 516 of the proximal arm514 may be tapered to a curved or rounded surface. Alternately, theproximal end 516 of the proximal arm 514 is shaped differently.Alternately, the entire proximal arm 514 is tapered. The rocker axle 510is located proximal to the trigger 308. As a result, depression of thetrigger 308 causes rotation of the rocker 508 such that the proximal end516 of the proximal arm 514 moves upward. Alternately, the trigger 308and the rocker axle 510 are positioned differently relative to oneanother. The rocker 508 also includes a distal arm 518 extending distalto the trigger 308, where the distal arm 518 has a distal end 520. Thedistal arm 518 may be formed into the rocker 508, or otherwise connectedto it. Referring also to FIG. 71, at least a portion of the distal arm518 may be bifurcated into two or more spaced-apart members 542. A post544 may be located at the distal end of each member 542. At least onepost 544 substantially may take the shape of a cylindrical orrectangular solid. Each post 544 is angled relative to the correspondingmember 542, protruding at least partly inward. This angle may besubstantially ninety degrees, or any other angle. Alternately, at leastone post 544 extends outward from the corresponding member. The posts544 are spaced apart from one another by a distance that is less thanthe distance separating the spaced-apart members 542. Alternately, atleast one post 544 is located at a position on the corresponding member542 other than its distal end. As one example, at least one post 544 maybe positioned a short distance proximal to the distal end of thecorresponding member 542.

Because the rocker axle 510 is located proximal to the trigger 308,depression of the trigger 308 causes the distal end 520 of the distalarm 518 to move downward. Alternately, the arms 514, 518 of the rocker508 are configured to move in another manner when the trigger 308 isdepressed. Alternately, the rocker 508 may be shaped or configureddifferently than described above.

A proximal slider 522 is also included within the handle 302. Theproximal slider 522 includes at least one flange 524 extending laterallyfrom at least one side thereof. Advantageously, a flange 524 extendsfrom each side of the proximal slider 522 for stability. Additionalflanges 524 may be provided, if desired. Ribs 526 are molded, formed,connected or otherwise attached to the inner surface of the handle 302.Two ribs 526 are spaced apart from one another a distance substantiallyequal to the thickness of the corresponding flange 524, such that eachflange 524 is configured to slide therebetween. Each pair of ribs 526substantially constrains the motion of the corresponding flange 524.Where the ribs 526 are substantially linear, and ribs 526 andcorresponding flanges 524 are utilized on opposite sides of the proximalslider 522, the ribs 526 substantially linearly constrain the motion ofthe corresponding flange 524. A spring 546 is connected at one end tothe handle 302, and is connected to or engages the proximal slider 522.The spring 546 is in compression, and thereby biases the proximal slider522 distally. A stop 547 may be connected to or defined in the innersurface of one or more of the handle shell members 502, where the stopor stops 547 are located distal to the proximal slider 522. The stop orstops 547 act to restrain the distal motion of the proximal slider 522,thereby defining a position that is the most distal the proximal slider522 can travel. Alternately, a different or additional mechanism,structure or method may be used to bias the proximal slider 522distally. Alternately, the spring 546 is initially neither in tensionnor compression, but is compressed by the rocker 508 during at least aportion of its travel.

The spring 546 stores energy within itself when it is in tension.Alternately, an energy storage device could be used in lieu of thespring 546. As one example, the energy storage device is a reservoir orcylinder of pressurized gas. Valves, tubing and/or other structure maybe used to route the pressurized gas to desired locations in the handle302 such that the energy stored in the gas is used to bias the proximalslider 522 distally, and/or to perform other actuation functions withinthe handle 302 and/or the tool 300. The gas may be carbon dioxide,nitrogen, a different gas, air, or a combination of gases. As anotherexample, a cylinder or source of vacuum may be used as an energy storagedevice. Valves, tubing and/or other structure may be used to route thevacuum to desired locations in the handle 302 such that the vacuum canbe used to bias the proximal slider 522 distally, and/or to performother actuation functions within the handle 302 and/or the tool 300.That is, compressed gas may be used for controlling the operation of thetool 300 instead of or in addition to providing energy storage. Asanother example, a battery may be used as an energy storage device.Wiring and actuators such as solenoids or motors may be provided withinthe handle 302 such that the stored electrical energy in the battery isused to bias or hold the proximal slider 522 distally, and/or to performother actuation functions within the handle 302 and/or the tool 300.That is, electromagnetic energy may be used for controlling theoperation of the tool 300 instead of or in addition to providing energystorage. Where such an alternate energy storage device is provided, thetrigger 308 may be configured differently, such that actuation of theanastomosis tool 300 may be performed simply by contacting the trigger308 with a finger, or moving the trigger 308 through a more limitedrange of motion. Alternately, the trigger 308 may be omitted altogether,and the anastomosis tool 300 may be actuated remotely by a computer,dedicated control station, handheld computing device, or other device.

A contact feature 528 is defined on the distal surface of the proximalslider 522. Alternately, the contact feature 528 is a separate elementconnected to the proximal slider 522. The contact feature 528 isconfigured to engage the proximal end 516 of the proximal arm 514 at orafter the time the trigger 308 is depressed, as described in greaterdetail below. The contact feature 528 is angled proximally and downwardalong a lower portion 530 thereof, and is substantially vertical alongan upper portion 532 thereof. Alternately, the contact feature 528 isshaped and/or angled differently.

The first cable or cables 480 are connected to the proximal slider 522in any appropriate way. As an example, at least one aperture or port(not shown) may be formed in the proximal slider 522, and at least onecable 480 is inserted into at least one aperture and secured thereto. Asother examples, an end of the cable or cables 480 may be wound aroundall of or a portion of, crimped to, welded to, or secured by adhesive tothe proximal slider 522. The proximal arm 514 of the rocker 508 may bebifurcated to allow the first cable or cables 480 to extendsubstantially along the longitudinal centerline of the handle 302 andbetween the bifurcations substantially without interference. Similarly,the lower portion 530 of the contact feature 528 may be bifurcated aswell. Where both the proximal arm 514 and the contact feature 528 arebifurcated, the two are aligned such that they contact one anotherduring at least a portion of the travel of the rocker 508.

A distal slider 534 is also included within the handle 302. The distalslider 534 includes a flange 536 extending outward from at least oneside thereof. Advantageously, a flange 536 extends from each side of thedistal slider 534 for stability. Additional flanges 536 may be provided,if desired. Ribs 538 are molded, formed, connected or otherwise attachedto the inner surface of the handle 302. Two ribs 538 are spaced apartfrom one another a distance substantially equal to the thickness of thecorresponding flange 536, such that each flange 536 is configured toslide therebetween. Each pair of ribs 538 substantially constrains themotion of the corresponding flange 536. Where the ribs 538 aresubstantially linear, and ribs 538 and corresponding flanges 536 areutilized on opposite sides of the distal slider 534, the ribs 538substantially linearly constrain the motion of the corresponding flange524.

A contact surface 548 is defined on at least a portion of the proximalsurface of the distal slider 534. The contact surface 548 may be curvedor angled. As one example, the contact surface 548 has a concavecurvature. Other shapes or configurations of the contact surface 548 maybe utilized. Alternately, the contact surface 548 is located on aportion of the distal slider 534 other than its proximal surface. Thedistal slider 534 may include a passage 550 through it to allow thecables 480, 490 to pass therethrough. Alternately, the passage 550 isnot provided in the distal slider 534, and the distal slider 534 isbifurcated or otherwise shaped to allow the cables 480, 490 to passthrough it. Alternately, the cables 480, 490 are routed through thehandle in such a way as to bypass the distal slider 534 altogether.

The distal slider 534 may include a lower guide 552. The lower guide 552extends downward from the remainder of the distal slider 534, and mayextend proximal to the contact surface 548. Further, the lower guide 552may be thinner than the remainder of the distal slider 534. Alternately,the lower guide 552 is not included in the distal slider 534, or may beconfigured differently relative to the remainder of the distal slider534. Optionally, the lower guide 552 may include a flange 554 extendingoutward from at least one side thereof. Advantageously, a flange 554extends from each side of the lower guide 552 for stability. Additionalflanges 554 may be provided, if desired. These flanges 554 provideadditional stability to the distal slider 534. Ribs 556 are molded,formed, connected or otherwise attached to the inner surface of thehandle 302. Two ribs 556 are spaced apart from one another a distancesubstantially equal to the thickness of the corresponding flange 554,such that each flange 554 is configured to slide therebetween. Each pairof ribs 556 substantially constrains the motion of the correspondingflange 554. Where the ribs 556 are substantially linear, and ribs 556and corresponding flanges 554 are utilized on opposite sides of thedistal slider 534, the ribs 556 substantially linearly constrain themotion of the corresponding flange 554.

A spring 540 is connected at one end to the distal slider 534 and at theother end to the handle 302. An aperture 558 may be provided in thelower guide 552, or in another part of the distal slider 534. One end ofthe spring 540 includes a hook or similar structure, which is receivedinto and held by the aperture 558. Alternately, the spring 540 isconnected to the distal slider 534 in a different way. The spring 540 isin tension, and thereby biases the distal slider 534 proximally.Alternately, a different or additional mechanism, structure or methodmay be used to bias the distal slider 534 proximally.

Referring also to FIG. 78, a holder 594 is connected to the innersurface of the handle 302. This connection may be accomplished in anyappropriate manner. As one example, a slot 602 may be defined in amember 604 or between two separate members 604 extending inward from theinner surface of each shell member 502, wherein a portion of the holder594 is held by the slot 602 such as by a pressure fit. The distal end595 of the holder 594 is held by the slot 602 such that it does notsubstantially move. Alternately, a different part of the holder 594 isheld by the slot 602, and/or the distal end 595 of the holder 594 isfree to move. Moving proximally from the distal end 595 of the holder594, the holder 594 is bifurcated by an opening 598 that extendssubstantially longitudinally. Two spaced-apart members 600 extendsubstantially proximally, each member 600 on an opposite side of theopening 598. At least the members 600 of the holder 594 have someflexibility, such that the members 600 can move up or down in responseto force applied to them. However, the members 600 are stiff enough toremain in a neutral position until that force is applied.

A stop 596 extends upward from each member 600. The stops 596 arepositioned and shaped to engage the bottom edge 570 of the contactsurface 548 of the distal slider 534. The holder 594 is substantiallyrestrained against longitudinal motion by its engagement with the slots602 in the shell members 502 ad/or members 604 defined in or on theshell members 502. Thus, by engaging the bottom edge 570 of the contactsurface 548 of the distal slider 534, the stops 596 substantiallyrestrain the distal slider 534 against proximal motion under theinfluence of the spring 540. The stops 596 are stiff enough, and extendupward enough, to provide this restraint. For example, the stops 596 maybe curved to match the curvature of the contact surface 548, such thatthey contact a portion of the contact surface. Alternately, contactbetween the distal slider 534 and the rocker 508 prevents the distalslider 534 from substantially moving proximally. This contact occursbetween the contact surface 548 of the distal slider 534 and the distaltip 520 of the distal arm 518 of the rocker 508. Alternately, thiscontact occurs between other or additional components of the distalslider 534 and/or the rocker 508.

The spring 540 stores energy within itself when it is in tension.Alternately, an energy storage device such as a reservoir or containerof pressurized gas, a battery, or other energy storage device could beused in lieu of the spring 540. Where a reservoir of pressurized gas isutilized, valves, tubing and other structure may be used to route thepressurized gas to desired locations in the handle 302 such that theenergy stored in the gas is used to bias the distal slider 534proximally, and/or to perform other actuation functions within thehandle 302 and/or the tool 300. Similarly, where a battery is utilized,wiring and actuators such as solenoids or motors may be provided withinthe handle 302 such that the stored electrical energy in the battery isused to bias or hold the distal slider 534 proximally, and/or to performother actuation functions within the handle 302 and/or the tool 300.Where such an alternate energy storage device is provided, the trigger308 may be configured differently, such that actuation of theanastomosis tool 300 may be performed simply by contacting the trigger308 with a finger, or moving the trigger 308 through a more limitedrange of motion. Alternately, the trigger 308 may be omitted altogether,and the anastomosis tool 300 may be actuated remotely by a computer,dedicated control station, handheld computing device, or other device.

The second cable 490 is connected to the distal slider 534 in anyappropriate way. As an example, at least one aperture or port (notshown) may be formed in the distal slider 534, and at least one cable480 is inserted into at least one aperture and secured thereto. As otherexamples, an end of the cable or cables 480 may be wound around all ofor a portion of, crimped to, welded to, or secured by adhesive to thedistal slider 534. The second cable 490 may have an amount of slack init when the distal slider 534 is in the first, predeployment positionshown in FIG. 70. The amount of slack, if any, is related to thedistance traveled by the distal slider 534 during actuation, asdescribed in greater detail below.

Optionally, the distal slider 534 includes a verification stub 560. Theverification stub 560 extends substantially upward from the upper end ofthe distal slider 534. Alternately, the verification stub 560 extendsfrom a different portion of the distal slider 534, or in a differentdirection. The verification stub 560 may extend into or through a slot562 through the handle 302. Because it is connected to the distal slider534, the verification stub 560 moves along the slot 562 in the handle302 when the distal slider 534 moves during operation, as describedbelow. As a result, the position of the verification stub 560 may beused to confirm visually whether a particular anastomosis tool 300 hasbeen actuated or not. That is, the verification stub 560 may be locatedin a first position before the anastomosis tool 300 is actuated, and ina second position after the anastomosis tool 300 is actuated, such thatthe user can determine whether the anastomosis tool 300 has beenactuated by viewing the position of the verification stub 560.

Optionally, the rocker 508 includes a ratchet 564 extendingsubstantially downward from a location distal to the rocker axle 510.Alternately, the ratchet 564 extends in a different direction. Theratchet 564 includes a member 566 at its lower end extendingsubstantially transverse to the remainder of the ratchet 564.Alternately, the member 566 extends in a different direction.Alternately, the member 566 is a notch or other element defined in theratchet 564. The ratchet 564 moves in conjunction with the rocker 508.Thus, when the trigger 308 is depressed and the distal end of the rocker508 moves downward, the ratchet 564 moves downward as well. A pawlfeature 568 is configured to engage the member 566 of the ratchet 564after the ratchet 564 has moved downward a particular distance, allowingthe ratchet 564 to continue to move downward after engagement, butpreventing the ratchet 564 from moving back upward past the pawl feature568 after engagement.

Alternately, the rocker 508, sliders 522, 534, and/or other mechanismsin the handle are not used, and a different mechanism or mechanisms areused to actuate the tissue effector 400 and complete the anastomosis.For example, a fluid logic mechanism may be used, where a container ofgas within the handle or a connection to a tank outside the handleprovides gas under pressure to a switching assembly or other mechanism.The switching assembly utilizes and/or directs the pressure of the gasto successively actuate the components of the tissue effector 400.Vacuum or liquid may be used instead of gas, if desired. As anotherexample, the handle 302 may include an electromechanical assembly underanalog or digital control, such that actuation of the trigger 308 orother component causes actuation of the tissue effector.

The operation of the anastomosis tool 300 will now be described.Referring to FIGS. 59 and 74, an end of the graft vessel 404 is incisedsubstantially in the longitudinal direction to form flaps 404 therein.At least one incision may be made in a different direction.Advantageously, two incisions are made to create two flaps 404 ofsubstantially the same size. However, the flaps 404 may be of differentsizes. Further, more than two flaps 404 may be created with more thantwo incisions. Alternately, a single flap 404 is made with a singleincision. The graft vessel 404 is loaded onto the staple holder 38 asdescribed above, such that each flap 408 is held between a graft clip412 in the closed position and a flap receiving surface 406, and thegraft vessel 404 extends between the arms 402 of the staple holder 38.Referring also to FIG. 70, the anastomosis tool 300 is initially in apre-deployment configuration. In this configuration, the distal arm 518of the rocker 508 is at an uppermost position, the trigger 308correspondingly extends outward from the handle 302 to its greatestextent, and the proximal arm 514 of the rocker 508 is at a lowermostposition. The distal end 520 of the distal arm 518 of the rocker 508 mayengage the contact surface 548 of the distal slider 534 at or near theuppermost end of the contact surface 548. This contact may be betweenthe posts 544 of the distal arm 518 and the contact surface 548, and/orbetween another portion of the distal arm 518 and the contact surface548. The stops 596 of the holder 594 hold the distal slider 534substantially in place against the proximal bias exerted by the spring540. Alternately, where the holder 594 is not used, contact between therigid distal arm 518 and the contact surface 548 holds the distal slider534 substantially in place against the proximal bias exerted by thespring 540. In the pre-deployment configuration, the proximal end 516 ofthe proximal arm 514 may be spaced apart from the lower portion 530 ofthe proximal slider 522, or may be in contact with the lower portion 530of the proximal slider 522. The proximal slider 522 is biased distallyto its most distal possible position. Alternately, the proximal slider522 is positioned differently in the pre-deployment configuration.Alternately, the rocker 508 and/or the trigger 308 may be in a differentposition in the pre-deployment configuration, particularly where therocker 508 and/or trigger 308 are shaped or configured differently thanshown in FIG. 70. If so, the rocker 508 may engage the proximal slider522 and/or the distal slider 534 in a different manner than describedabove.

Referring also to FIG. 77, when the handle 302 is in the pre-deploymentconfiguration, the time is t=0. The position 590 of the proximal slider522 is at an initial position, and the position 592 of the distal slider534 is also at an initial position. The positions 590, 592 of thesliders 522, 534 on the graph of FIG. 77 are qualitative, and are shownwith respect to an arbitrary point selected between them. That is, thegraph of FIG. 77 illustrates an exemplary set of motions of the sliders522, 534 over time.

The first cable or cables 480 are connected to the proximal slider 522and the second cable 490 is connected to the distal slider 534, asdescribed above. In the pre-deployment configuration, both cables 480,490 include some slack, such that a small initial motion of the trigger308 takes up the slack and causes the cables 480, 490 to becometensioned. In this way, small motions of the trigger 308 beforedeployment is intended do not begin the actuation of the anastomosistool 300. Alternately, one or more of the cables 480, 490 are tensionedin the pre-deployment configuration.

The second cable 490 is also connected to the sled 482 in the tissueeffector 400, as described above. Referring also to FIGS. 64 and 68-69,in the pre-deployment configuration the sled 482 is positioned such thateach ramp element 446 is located within the corresponding passage 440 inthe corresponding arm 402, proximal to the connector bays 448.Similarly, in the pre-deployment configuration the sled 482 ispositioned such that each vein knife 432 is located proximal to the veinflap 408 held between the graft clip 412 and the corresponding flapreceiving surface 406. Alternately, the sled 482 is positioneddifferently in the pre-deployment configuration. For example, each rampelement 446 may be positioned initially in a location distal to theconnector bays 448. Referring also to FIG. 72, each flap 408 is heldbetween a graft clip 412 and a flap receiving surface 406 as describedabove, such that the graft vessel 404 extends between the arms 402 ofthe tissue effector 400. The flaps 408 are held on the undersides of thearms 402. Each flap 408 is held by the corresponding graft clip 412 suchthat a portion of the flap 408 at its root 405, which is the portion ofthe flap 408 at or in proximity to its intersection with the tubularportion of the graft vessel 404,is exposed. The root 405 of each flap408 is configured to contact the outer surface of the target vessel, asdescribed in greater detail below.

Optionally, the orientation of the tissue effector 400 may be changedrelative to the handle 302. Thus, the tissue effector 400 can beoriented relative to the target vessel such that the anvil arm 14 isaligned with it, and the handle 302 can be placed in a convenientposition for the user. To re-orient the tissue effector 400, the userdepresses the buttons 278, disengaging the teeth 284 of the cog 282 fromthe detents 310 of the receiving opening 309. The tissue effector 400 isthen rotated to the desired orientation. The buttons 278 are thenreleased, allowing the teeth 284 of the cog 282 to engage once again thedetents 310 of the receiving opening 309. The cog 282 is thus heldsecurely in place in its new orientation.

Referring to FIGS. 34 and 74, in the pre-deployment configuration, thedistal end of the anvil arm 14 is spaced apart from the staple holder38. Referring also to FIG. 75, the anvil arm 14 is inserted through thewall of the target vessel 580. The target vessel 580 may be a coronaryartery, if the anastomosis tool 300 is used in the course of a CABGprocedure, or any other appropriate bodily vessel or structure.Advantageously, the anvil arm 14 has a cross-section small enough toallow it to enter the target vessel 580 easily and to result in minimalor no leakage from the target vessel after the anvil arm 14 is removed.The distal tip of the anvil arm 14 may be sharp such that the anvil arm14 itself penetrates the wall of the target vessel 580, resulting in anopening in the wall of the target vessel 580 substantially the same sizeas the cross-section of the anvil arm 14. Alternately, a sharpretractable projection, such as but not limited to the blade 78 of FIGS.13-14 or the blade 84 of FIGS. 15-16, is provided at the distal end ofthe anvil arm 14. The retractable projection is extended to allow thedistal end of the anvil arm 14 to penetrate the wall of the targetvessel 580, then retracted into the anvil arm 14. The retractableprojection may be a wire, a blade, a substantially conical member, ascrew or a screw-tipped rod, or any other sharp structure or mechanismcapable of penetrating the wall of the target vessel 580. Such aretractable projection alternately may be as described in U.S. PatentApplication serial no. 10/134,081, which is herein incorporated byreference in its entirety. Alternately, a separate mechanism orstructure is used to penetrate the wall of the target vessel 580, andthe anvil arm 14 is later inserted through that penetration.Alternately, the cutter 200 includes a sharp point at its distal end,where that sharp point extends out of the distal end of the anvil arm 14to puncture the wall of the target vessel 580. If so, the cutter 200 maybe actuated in a direction the reverse of that described below.

Referring also to FIGS. 36 and 75, after insertion, the distal end ofthe anvil arm 14 enters the lumen of the target vessel 580. The anvilarm 14 is advanced into the target vessel 580 until a tissue stop 220 onthe anvil arm 14 encounters the edge of the penetration in the wall ofthe target vessel 580. The tissue stop 220 is substantially flat and/orblunt, and extends upward or in another direction relative to the anvilarm 14 to increase the height and/or width of the anvil arm 14. Thetissue stop 220 increases the cross-section of the anvil arm 14 suchthat the anvil arm 14 cannot easily move further into the penetration inthe wall of the target vessel 580 after the tissue stop 220 encountersthe outer wall of the target vessel 580. Because the tissue stop 220 isblunt, it does not penetrate the wall of the target vessel 580 or act toexpand the size of the existing penetration. Thus, the distance betweenthe distal end of the anvil arm 14 and the tissue stop 220 substantiallydetermines how much of the anvil arm 14 is allowed into the lumen of thetarget vessel 580.

Optionally, the distal end of the anvil arm 14 is stabilized afterinsertion into the target vessel 580. This stabilization may beperformed by, for example, extending pins (not shown) from the stapleholder 38 to the anvil arm 14, where the pins act to hold the distal endof the anvil arm 14 substantially in place. The pins may be sized andshaped to fit into depressions, slots or other features on the anvil arm14. In this way, potential deflection of the distal end of the anvil arm14 may be further reduced without the need for increasing the stiffnessof the anvil arm 14. After the connectors 464 have been deployed, thepins are retracted or otherwise moved away from the anvil arm 14,freeing it. Different or additional mechanisms, structures or methodsmay be used to stabilize the anvil arm 14. Optionally, a different partof the anvil arm 14 is stabilized in addition to or instead of thedistal end of the anvil arm 14.

Next, referring also to FIGS. 44 and 70, an operator depresses thetrigger 308 of the anastomosis tool 300. As a result, the rocker 508begins to rotate about the rocker axle 510, such that the distal arm 518moves downward and the proximal arm 514 of the rocker 508 moves upward.As the trigger 308 is depressed, the distal end 520 of the distal arm518 moves downward. The stops 596 of the holder 594 continue to hold thedistal slider 534 substantially in place against the proximal biasexerted by the spring 540. Thus, the distal slider 534 does notsubstantially move as the trigger 308 is initially depressed. Thecontact surface 548 of the distal slider 534 is curved to substantiallymatch the travel of the distal end 520 of the distal arm 518. That is,the radius of curvature of the contact surface 548 relative to therocker axle 5 10 is substantially the same as the path of motion of thedistal end 520 of the distal arm 518 as the rocker 508 rotates, and thusdoes not substantially interfere with the motion of the distal arm 518.If the holder 594 is not used, the distal end 520 of the distal arm 518holds the distal slider 534 in substantially the same position as thedistal arm 518 moves relative to the contact surface 548, due to thematch between the curvature of the contact surface 548 and the motion ofthe distal end 520 of the distal arm 518. Alternately, the contactsurface 548 is configured differently. Further, the distal slider 534may be configured to move as the trigger 308 is initially depressed, ifdesired.

The proximal end 516 of the proximal arm 514 moves upward as the trigger308 is depressed, and contacts the lower portion 530 of the contactfeature 528 of the proximal slider 522 if it is not initially in contactwith the proximal slider 522. As the proximal end 516 of the proximalarm 514 continues to move upward, it continues to engage the lowerportion 530 of the contact feature 528 of the proximal slider 522. Thelower portion 530 of the contact feature 528 is shaped such that acomponent of force exerted by the proximal end 516 of the proximal arm514 on that lower surface 530 is converted into a substantiallytranslational force acting on the proximal slider 522 to urge itproximally. As one example, the lower portion 530 of the contact feature528 is angled proximally and downward. Further, the ribs 526 andcorresponding flanges 524 of the proximal slider 522 substantiallylinearly constrain the motion of the proximal slider. The angle of thelower surface 530 relative to the arcuate motion of the proximal end 516of the proximal arm 514 results in the conversion of the substantiallyarcuate motion of the proximal end 516 of the proximal arm 514 tosubstantially linear motion of the proximal slider 522.

Thus, the upward motion of the rocker 508 against the lower portion 530of the contact feature 528 of the proximal slider 522 urges the proximalslider 522 in the proximal direction, against the bias of the spring 546connected to the proximal slider 522 and the handle 302. Referring alsoto FIG. 77, this is time t=1, the proximal slider 522 has movedproximally from time t=0, and the distal slider 534 has remained insubstantially the same position it occupied at time t=0. As the proximalslider 522 moves proximally, it takes up slack in the first cable orcables 480 connected thereto, if slack is present. The first cable orcables 480 are fixed to the anvil 10. Because the anvil 10 is in turnfixed relative to the shaft 304, the proximal motion of the first cableor cables 480 removes slack from, then tensions, the first cable orcables 480. The first cable or cables 480 pass through at least aportion of the cable housing 306. As described above, the cable housing306 curves between the shaft 304 and the tissue effector 400. Thetension in the first cable or cables 480 causes the cable housing 306 tomove. That is, the tension in the first cable or cables 480 acts uponthe flexible cable housing 306, causing its curvature to decrease.Although the cable housing 306 is at least partially flexible, the cablehousing 306 possesses stiffness longitudinally. Thus, as the curvatureof the cable housing 306 decreases, the distal end of the cable housing306 moves distally. Referring also to FIG. 58, the staple holder 38 isbiased away from the anvil 10 by a biasing element 475, which tends tomove the tissue effector 400 to an open position. The biasing element475 may be a coil spring, leaf spring, or any other structure ormechanism capable of applying a biasing force. When the tension in thefirst cable or cables 480 causes the distal end of the cable housing 306to move distally, the distal end of the cable housing 306 exerts a forceon the anvil 10 that overcomes the bias of the biasing element 475,causing the anvil 10 to rotate about a pivot point such as the pin 226to a standby position. In this way, the anvil arm 14 remainssubstantially stationary within the target vessel 580, while the stapleholder 38 rotates. Alternately, the staple holder 38 and anvil 10 may beactuated to move between the position shown in FIG. 34 and the positionshown in FIG. 44 by any structure, mechanism or method.

Alternately, a second cable housing (not shown) is provided. If so, thefirst cable or cables 480 may extend through the cable housing 306 asdescribed above, and the second cable or cables 490 may extend throughthe second cable housing. In this way, the forces exerted along thefirst cable or cables 480 and cable housing 306 are substantiallyisolated from the forces acting along the second cable or cables 490 andthe second cable housing.

Referring also to FIGS. 29-31, 44 and 76, as the staple holder 38 andanvil 10 move closer together, the staple holder 38 holds a root 405 ofeach flap 408 against or in proximity to the outer surface of the targetvessel. For clarity, the flaps and graft vessel are not shown in FIG.44. That is, the roots 405 of the flaps 408 are apposed to the outerwall of the target vessel 580. As a result, a portion of the intimallayer of the graft vessel 404 at the root 405 of each flap 408 is placedagainst the outer wall of the target vessel 580. The flaps 408 are heldby the staple holder 38 in a substantially fixed position relative tothe surface of the target vessel 580, such that the end of the graftvessel 404 is substantially immobile relative to the wall of the targetvessel 580. Thus, the position of the end of the graft vessel 404relative to the wall of the target vessel 580 remains substantiallyunchanged throughout the duration of the anastomosis procedure. Further,after the anvil arm 14 has been inserted into the lumen of the targetvessel 580, the contact surface 206 of the anvil arm 14 is substantiallyin contact with the inner surface of the wall of the target vessel 580.The perimeter of the end of the graft vessel 404 defines a closed areaon the wall of the target vessel. The location of a connection madebetween the end of the graft vessel 404 and the wall of the targetvessel is substantially registered with an opening made within theclosed area in the wall of the target vessel, regardless of the order inwhich the connection and the opening are made. Further, the position ofthe end of the graft vessel 404 relative to the wall of the targetvessel 580 substantially maintains position registration throughout theduration of the anastomosis procedure relative to the opening in thewall of the target vessel through which the anvil arm 14 is inserted.

As the staple holder 38 and anvil 10 move together, the engagementmember 216 engages the receiver 218. As described above, the receiver218 is defined in the sled 482. However, the receiver 218 may be aseparate component from the sled 482. Further, if the optional safetyfeature 210 is utilized, the relative motion of the staple holder 38 andthe anvil 10 causes the staple holder 38 to contact the safety feature210 and urge it downward against its upward bias. Consequently, the tip212 of the safety feature 210 is moved downward out of engagement withthe safety recess 214 of the cutter 200. Alternately, another structureor mechanism is configured to engage the safety feature 210 when thestaple holder 38 and anvil 10 are moved together, so as to urge the tip212 out of the safety recess 214. Thus, in the standby position, thecutter 200 is freed for translation along the channel 246.

Optionally, an interface structure 238 may be connected to or formedinto the staple holder 38. The interface structure 238 engages the anvil10 or a component associated with the anvil 10 as the staple holder 38and the anvil 10 move to the standby position, such as by snapping ontoa corresponding feature (not shown) on the anvil 10. By doing so, theinterface structure 238 holds the staple holder 38 substantially fixedrelative to the anvil 10, in order to maintain registration between thetarget vessel, the graft vessel, the anvil 10 and the staple holder 38.The interface structure 238 may be a tab, rail, bump, or any otherfeature that is capable of engaging a corresponding feature and holdingthe staple holder 38 substantially fixed relative to the anvil 10.Alternately, the interface structure 238 is formed into or connected tothe anvil 10 and engages a corresponding feature on the staple holder38.

Referring also to FIG. 70, the user continues to depress the trigger308. As a result, the rocker 508 continues to rotate about the rockeraxle 510 such that the distal end 520 of the distal arm 518 continues tomove downward, and the proximal end 516 of the proximal arm 514continues to move upward. As the proximal end 516 of the proximal arm514 continues to move upward, its contact with the lower portion 530 ofthe contact feature 528 of the proximal slider 522 continues to urge theproximal slider 522 proximally. When the proximal end 516 of theproximal arm 514 has reached a position at or near the intersectionbetween the two portions 530, 532 of the contact feature 528, theproximal slider 522 has moved substantially as far proximally as it willmove during actuation of the anastomosis tool 300. Further, when theproximal end 516 of the proximal arm 514 has reached that position, thestaple holder 38 and the anvil arm 14 are still in the standby position.Referring also to FIG. 77, this is time t−2, at which the proximalslider 522 has moved proximally from its position at time t−1, and hasreached its most proximal position. The distal slider 534 is insubstantially the same position that it was in at time t=1.

The user continues to depress the trigger 308. As the proximal end 516of the proximal arm 514 continues to move upward, it moves past theintersection between the two portions 530, 532 of the contact feature528, thereby contacting the upper portion 532 of the contact feature528. The upper portion 532 of the contact feature 528 providessubstantially no resistance to the continued rotation of the rocker 508,because it is substantially vertical or angled in a proximal directionas it extends upward. The proximal end 516 of the proximal arm 514 thusmoves upward rapidly. Alternately, the speed of the motion of theproximal end 516 of the proximal arm 514 is controlled to be the same asor slower than its speed while it contacts the lower portion 530 of thecontact feature 528. During the upward motion of the proximal end 516 ofthe proximal arm 514, the proximal slider 522 may move distally at leastslightly due to the arcuate motion of the proximal end 516 of theproximal arm 514 relative to the non-arcuate upper portion 532 of thecontact feature 528.

As the proximal end 516 of the proximal arm 514 moves upward along theupper portion 532 of the contact feature 528, the distal end 520 of thedistal arm 518 continues to move downward along the contact surface 548of the distal slider 534. As described above, the posts 544 at thedistal end 520 of the distal arm 518 are spaced apart from one another,such that a gap is present between them. The distal arm 518 may contactthe contact surface 548 via the posts 544 during at least a portion ofits travel. As the distal end 520 of the distal arm 518 moves downward,the posts 544 reach the bottom edge 570 of the contact surface 548. Therocker 508, the proximal slider, and the distal slider 534 arepositioned relative to one another and shaped such that the posts 544reach the bottom edge 570 of the contact surface 548 at substantiallythe same time that the proximal end 516 of the proximal arm 514 reachesthe intersection between the two portions 530, 532 of the contactfeature 528 of the proximal slider 522.

Referring also to FIG. 78, when the posts 544 reach the bottom edge 570of the contact surface 548, they contact the members 600 of the holder594. As the distal end 520 of the distal arm 518 continues to movedownward, the posts 544 thereby press the members 600 downward. As aresult, the stops 596 are moved out of engagement with the bottom edge570 of the contact surface 548, such that the stops 596 no longercontact the distal slider 534. Consequently, the stops 596 no longerrestrain the distal slider 534 against proximal motion under theinfluence of the spring 540. The width of the lower guide 552 is lessthan the width of the gap between the posts 544, and the lower guide 552is substantially aligned with the gap between the posts 544. Thus, afterthe stops 596 have been pushed below the bottom edge 570 of the contactsurface 548 of the distal slider 534, the lower guide 552 is free toslide through the gap between the posts 544 and through the proximal endof the holder 594. The proximal motion of the distal slider 534 thustakes up the slack (if any) in the second cable 490 connected to thedistal slider 534, then causes that second cable 490 to move proximally.Referring also to FIG. 77, this is time t=3, at which the distal slider534 has rapidly moved proximally from its position at time t=2, and theproximal slider 522 has moved slightly in the distal direction from itsposition at time t=2.

Referring also to FIG. 58, this proximal motion of the second cable 490urges the sled 482, which also is connected to the second cable 490,into motion. As described above, at least one channel 496 is defined inthe staple holder 38, and the second cable 490 is guided by acorresponding channel 496. The staple holder 38 is shaped such that thechannel 496 curves and causes the second cable 490 to curve back in aproximal direction. The second cable 490 is connected to the sled 482.Thus, the curvature of the channel 496 causes the second cable 490 tocurve, such that the proximal motion of the second cable 490 pulls thesled 482 distally. In this way, proximal motion of the distal slider 534causes the sled 482 to move distally.

Referring also to FIGS. 64 and 68-69, the sled 482 includes one or moreramp elements 446, each movable within a corresponding passage 440 in anarm 402 of the staple holder 38, as described above. Initially, the sled482 is positioned such that each ramp element 446 is proximal to themost proximal connector bay 448 connected to the corresponding passage440. Thus, as the second cable 490 is tensioned and moved proximally bythe distal slider 534, and the sled 482 moves distally as a result, eachramp element 446 moves distally in its corresponding passage 440.

For convenience in describing the deployment of staples 464, the motionof one ramp element 446 through the corresponding passage 440 will bedescribed; the motion of each additional ramp element 446 through itscorresponding passage 440 occurs in the same or a similar manner.Referring to FIG. 64, as the ramp element 446 moves distally from itsinitial position, its distal end 474 contacts the most proximalconnector deployer 452. As described above, each connector deployer 452initially is in a first position in which its outer end 454 extends intothe passage 440. When the distal end 474 of the ramp element 446contacts the most proximal connector deployer 452, it urges thatconnector deployer 452 into the corresponding connector bay 448. Thedistal end 474 of the ramp element 446 may be shaped such that its innersurface 476 curves or angles relative to the direction of travel of theramp element 446. Thus, when the distal end 474 of the ramp element 446encounters the outer end 454 of the most proximal connector deployer452, a component of the force it exerts on the connector deployer 452 issubstantially parallel to the longitudinal centerline of thecorresponding connector bay 448. That centerline may be substantiallyperpendicular to the direction of travel of the ramp element 446, or maybe otherwise oriented relative to the direction of travel of the rampelement 446.

As a result of contact with the distal end 474 of the ramp element 446,the connector deployer 452 begins to move through the correspondingconnector bay 448, away from the passage 440. A connector 464 is locatedin the connector bay 448, inward from the connector deployer 452. Thetines 466 of the connector 464 initially may be biased against at leastpart of the corresponding connector bay 448 as described above, or theconnector 464 may otherwise be held within the connector bay 448 priorto motion of the connector deployer 452. As the connector deployer 452moves, it exerts a force on the corresponding connector 464, overcomingthe force with which the connector 464 is initially held in place andpushing the connector 464 inward. As the connector 464 is urged inward,the registration element 458 (if used) translates along the registrationfeature 462 of the connector bay 448. The registration element 458reduces or eliminates lateral cocking of the connector deployer 452during its translation through the connector bay 448, such that theconnector deployer 452 is maintained in substantially the sameorientation throughout its travel.

Referring also to FIG. 61 (in which the graft vessel and target vesselare not shown for clarity), as the connector deployer 452 urges theconnector 464 out of the connector bay 448, the tines 466 of theconnector 464 move out of the connector bay 448, penetrate the root 405of the flap 408 held against the inner surface 450 of the arm 402, thenpenetrate the wall of the target vessel 580. One or more of the arms 402may be angled relative to a horizontal plane to facilitate connectingthe flaps of the graft vessel 404 to the wall of the target vessel 580,where that angle is chosen to place connectors in a desired orientationrelative to the surface of the target vessel 580. Advantageously, thestaples 464 enter the target vessel substantially perpendicular to it.However, the staples 464 can enter the target vessel at a differentangle, and/or at different angles relative to one another.

After the tines 464 have completely penetrated the wall of the targetvessel, they encounter corresponding staple bending features 572 in theanvil arm 14. The staple bending features 572 are depressions in thesurface of the anvil arm 14, aligned with the connector bays 448 suchthat at least one tine 466 of at least one connector 464 encounters astaple bending feature 572 upon being pushed out of its connector bay448. One or more of the staple bending features 572 may be configureddifferently, or may be omitted altogether. As the connector deployer 452continues to urge the connector 464 out of the connector bay 448 andtoward the anvil arm 14, the tines 464 of the connector 464 are pressedinto the staple bending features 572. Thus, the force transmitted fromthe ramp element 446 to the connector deployer 452 presses the tines 464into the staple bending features 572, causing them to deflect. The tines464 may be deflected in any direction suitable for holding the flap 408to the graft vessel 404.

When the widest portion of the distal end 474 of the ramp element 446encounters the outer end 454 of the connector deployer 452, theconnector deployer 452 reaches the end of its stroke through theconnector bay. The connector 464 and the corresponding staple bendingfeature or features 572 are configured such that the deflection of thetines 446, and thus the deployment of the connector 464, issubstantially complete when the corresponding connector deployer 452reaches the end of its stroke. The ramp element 446 then continues itsmotion through the passage 440 to encounter the next connector deployer452, such that the staples 464 in each arm 402 are deployedsequentially. Alternately, the ramp element 446 and passage 440 areconfigured such that the ramp element 446 moves in substantially thesame direction as the sliders 452, or is otherwise connected to thesliders 452, such that two or more of the sliders 452 are actuatedsubstantially simultaneously. That is, the sliders 452 may be actuatedin series, in parallel, or in a different way. For example, the sliders452 may be selectively actuated, such that a selected number of staples464 can be deployed. The user can deploy a selected number of staples464 based on the size of the graft vessel 404 or other relevant factors.That is, the staple line (the length along the target vessel 580 alongwhich staples 464 are deployed) is adjustable. Such adjustment may beperformed in any appropriate manner, such as by adjusting the distancetraveled by each ramp element 446 during deployment of the staples 464.Alternately, other mechanisms or structures may be used to deploy thestaples 464 from the connector bays 448 in a desired sequence.

As described above, the staple holder 38 includes two spaced-apart arms402. A ramp element 446 proceeds distally through a correspondingpassage 440 in each arm 402. Further, the connector bays 448 in each arm402 are aligned in a substantially bilaterally symmetric manner. Thus,as the sled 482 translates distally, the distal end 474 of each rampelement 446 encounters a connector deployer 452 at substantially thesame time, such that a connector 464 is deployed from each arm 402 atsubstantially the same time. As a result, the staple holder 38sequentially deploys pairs of staples 446 into tissue as the rampelements 446 move distally. Alternately, the connector bays 448 arestaggered, such that staples 464 from each arm 402 are deployed atdifferent times than staples from the other arm 402.

The sled 482 also includes vein knives 432. Each vein knife 432translates through a corresponding vein knife passage 430 defined by afirst channel 426 in the graft clip 412 and a second channel 428 in theflap receiving surface 406, as described above. The distal end 474 ofeach vein knife 432 is sharp. As described above, the vein knives 432are initially in a first position, where the distal end 474 of each veinknife 432 is located proximal to the root 405 of the corresponding flap408. As the second cable 490 is tensioned and pulled toward the handle302 by the distal slider 534, the sled 482 moves distally. The veinknives 432, which are connected to the sled 482move distally as wellthrough the corresponding vein knife passages 430.

As each vein knife 432 moves distally, its sharp distal end 474 engagesthe proximal edge of the root 405 of the corresponding flap 408,entering the tissue of the flap 408 and beginning to make an incisiontherein. The serrations 438 on the graft clip blades 436 assist inholding the flap 408 as the corresponding vein knife 432 incises it.Alternately, those serrations 438 may assist in incising the flap 408,depending on their configuration. In addition, the serrations 438 mayassist in holding the excess tissue incised from each flap 408, afterthe vein knife 432 has made an incision through the entire flap. Thevein knives 432 do not extend as far in the distal direction as the rampelements 446. Thus, as the sled 482 translates distally, the distal end474 of each ramp element 466 reaches any given longitudinal positionbefore the blade 434 of the corresponding vein knife 432. Consequently,the ramp element 466 causes a staple 446 to deploy at a particularlongitudinal position before the corresponding vein knife 432 extendsthe incision in the flap 408 to that longitudinal position. By staplingbefore incising at any given longitudinal position, each flap 408 isheld securely as it is cut by the corresponding vein knife 432.Alternately, at any given longitudinal position, the flap 408 is incisedduring or before deployment of a staple 446 at that position. Each veinknife 432 is positioned to cut the flap 408 far enough from the deployedstaples 446 to minimize or eliminate interference with these staples446, but close enough to the staples 446 to cut away excess tissue onthe flap 408 that is not needed for the finished anastomosis.

Referring also to FIGS. 45, 58 and 68, the cutter 200 has been freed fortranslation. The cutter 200 is urged distally by the receiver 218, whichengages the engagement feature 216 of the cutter 200. The receiver 218may be defined in the sled 482, as described above. As the sled 482 ispulled distally by the second cable 490, the receiver 218 movesdistally, thereby urging the engagement feature 216 of the cutter 200distally. Alternately, the receiver 218 is not defined in the sled 482.Instead, the receiver 218 is a separate structure that may be connectedto the sled 482, and that is configured to travel along a guidestructure 241. The guide structure 241 is a rail or other structurealong which the receiver 218 slide, and the receiver 218 interfaces withand translates along the rail. Thus, the guide structure 241 guides thetranslation of the receiver 218. A cavity 240 is provided in the stapleholder 38 adjacent to the guide structure 241 to allow for motion of thereceiver 218 along the guide structure 241. The cavity 240 is sized toallow the receiver 218 to translate freely. Alternately, the guidestructure 241 is a hollow channel defined within the staple holder 38,such that the walls of the channel guide the translation of the receiver218. Alternately, the guide structure 241 may be any other structure ormechanism capable of guiding the translation of the receiver 218. Theguide structure 241 is substantially aligned with the anvil arm 14. Thatis, the longitudinal centerline of the guide structure 241 issubstantially parallel to the longitudinal centerline of the anvil arm14. Thus, motion of the receiver 218 along the guide structure 241causes translation of the engagement feature 216 and thereforetranslation of the cutter 200 substantially parallel to the centerlineof the anvil arm 14. The receiver 218 may be actuated to translate alongthe guide structure 241 by the second cable 490, which transmits forcefrom the handle 302. Alternately, the actuator may convert stored energyto force that is applied to the cutter. Such stored energy may beprovided by a spring, battery, source of compressed gas, or othersource. Alternately, any mechanism, structure or method, using storedenergy or not, may be used to translate the receiver 218 along the guidestructure 241. The particular mechanism, structure or method used tocause translation of the cutter 200 is not critical to the invention.

The upper surface 252 of the cutter 200 is substantially planar proximalto the projection 208. The biasing element 260 contacts the uppersurface 252 of the cutter 200 and biases the cutter 200 downward. Thecutter 200 includes a keel 264 that extends downward. The keel 264 maybe formed into the cutter 200, or may be a separate component connectedto the cutter 200. The keel 264 is substantially as wide as the adjacentportion of the cutter 200. However, the keel 264 may be wider ornarrower than the adjacent portion of the cutter 200. The keel 264 ispositioned at or near the distal end of the cutter 200. Alternately, thekeel 264 may be positioned at a different location on the cutter 200.

Referring to FIG. 43A, another embodiment of a cutter 200 is shown. Asdescribed above, the cutter 200 includes at least one projection 208extending substantially upward from a position at or near its distalend, and an engagement feature 216 extending upward from the uppersurface 252 of the cutter 200. In this embodiment, the keel 264 of thecutter 200 is spaced apart from the projection 208, differing from theembodiment of FIG. 37-38 in which the keel 264 is adjacent to theprojection 208. By spacing the keel 264 apart from the projection 208,the keel 264 can project a smaller distance downward while moving theprojection 208 substantially the same amount upward and downward.Consequently, the keel 264 as a whole can be made smaller.

Referring to FIG. 43B, another embodiment of a cutter 200 is shown. Asdescribed above, the cutter 200 includes at least one projection 208extending substantially upward from a position at or near its distalend, and an engagement feature 216 extending upward from the uppersurface 252 of the cutter 200. In this embodiment, the cutter 200includes a first keel 264 and a second keel 265. The first keel 264 maybe configured similarly to the keel 264 of FIG. 43, and the second keel265 may be configured similarly to the keel 265 of FIG. 43A. The firstkeel 264 extends further below the body of the cutter 200 than thesecond keel 265. A third lower opening (not shown) is defined through alower surface 256 of the anvil 10, in addition to the first loweropening 254 and the second lower opening 268. The third lower opening isspaced apart from the second lower opening 268, and is positioned distalto the second lower opening 268. The first keel 264 initially extendsinto the second lower opening 268, and the second keel 265 initiallyextends into the first lower opening 254.

As shown in FIG. 45, the keel 264 initially extends into the first loweropening 254, which is defined through a lower surface 256 of the anvil10. The keel 264 may extend completely through the first lower opening254, such that its lowest point extends outside the anvil 10. The keel264 is biased downward into the first lower opening 254 as a result ofthe downward force exerted on the cutter 200 by the biasing element 260.While the keel 264 is biased into the first lower opening 254, theprojection 208 remains below the contact surface 206 of the anvil arm14. In this way, the projection 208 does not extend out of the anvil arm14 while the anvil arm 14 is inserted into the wall of a target vessel.Where the cutter 200 of FIG. 43A is used, the keel 264 need not extendinto or through the first lower opening 254 as far as the keel 264 ofthe cutter 200 of FIGS. 37-38. As a result, less clearance for themotion of the keel 264 need be provided, and the tissue effector 400 maybe made more compact. The first lower opening 254 extends along a fixedlength of the lower surface 256 of the anvil 10. As the cutter 200translates distally, the keel 264 continues to remain at least partiallywithin the first lower opening 254, such that the projection 208continues to remain below the contact surface 206 of the anvil arm 14.Initially, the keel 264 may be positioned proximal to the distal end ofthe first lower opening 254. The length of the first lower opening 254is selected to cause the projection 208 to remain below the contactsurface 206 of the anvil arm 14 across that distance. That is, thisdistance is selected such that the projection 208 on the cutter 200 doesnot engage the wall of the target vessel until the projection 208 ispositioned within the circumference of the graft vessel. That is, theconnection between the graft vessel and the target vessel substantiallydefines a closed area, and the projection 208 is configured to engagethe wall of the target vessel within that closed area. In this way, theprojection 208 makes an incision completely within the connectionbetween the graft vessel and the target vessel, completing theanastomosis between the two vessels and minimizing or eliminatingleakage at the anastomosis site. While the projection 208 on the cutter200 remains below the upper surface of the anvil arm 14, it neitherengages nor cuts the wall of the target vessel.

Referring also to FIG. 46, the cutter 200 continues to advance distallyas the receiver 218 continues to urge the engagement feature 216distally. As described above, at least the distal end of the cutter 200is biased downward. As the cutter 200 advances distally, the keel 264encounters the distal end of the first lower opening 254. Thisencounter, and the continued proximal translation of the cutter 200,causes the keel 264 to move upward relative to the anvil arm 14. Thekeel 264 and/or the distal end of the first lower opening 254 may beconstructed to provide a smooth, gradual upward motion of the keel 264,such as by providing a gradual slope on the keel 264 and/or the distalend of the first lower opening 254. Alternately, the keel 264 and/or thedistal end of the first lower opening 254 may be constructed to allow orcause the keel 264 to move upward abruptly upon encountering the distalend of the first lower opening 254. The upward motion of the keel 264causes the distal end of the cutter 200 and the projection 208 to moveupward. Thus, the size and position of the first lower opening 254,including the position of the distal end of the first lower opening 254,control the motion of the cutter 200 and the projection 208 in thevertical direction.

Where the cutter 200 of FIG. 43A is used, the keel 264 contacts thedistal end of the first lower opening 254 in the same manner as thecutter of FIGS. 37-38. By spacing the keel 264 apart from the projection208, the projection 208 may be protected from inadvertent contact withthe distal end of the first lower opening 254. The initial position ofthe cutter 200 relative to the remainder of the tissue effector 400 maybe different than that of the cutter 200 of FIGS. 37-38, to ensure thatthe projection 208 enters the wall of the target vessel at a selectedpoint relative to the tissue effector 400. Where the cutter 200 of FIG.43B is used, as the cutter 200 is urged distally, the second keel 265and the first lower opening 254 are configured such that the second keel265 contacts the distal end of the first lower opening 254 before thefirst keel 264 can contact the distal end of the second lower opening268. In this way, the distal end of the cutter 200 is prevented fromcontacting the distal end of the second lower opening 268.

As the distal end of the cutter 200 moves upward, the projection 208moves upward through the upper opening 248 in the anvil arm 14. Thecontact surface 206 of the anvil arm 14 is substantially adjacent to theinner surface of the wall of the target vessel. Thus, upward motion ofthe projection 208 through the upper opening 248 and above the contactsurface 206 of the anvil arm 14 causes the projection 208 to enter thewall of the target vessel. The cutter 200 continues to move distally,such that the keel 264 moves out of the first lower opening 254completely and contacts the bottom surface 266 of the channel 246 of theanvil arm 14. The projection 208 is sized such that the projection 208completely penetrates the wall of the target vessel when the keel 264has moved proximally to the first lower opening 254 and is in contactwith the bottom surface 266 of the channel 246. That is, at least aportion of the projection 208 passes through the wall of the targetvessel and enters the lumen of the target vessel. This initialpenetration of the wall of the target vessel defines the starting pointof an arteriotomy performed on the target vessel by the projection 208.The starting point of the arteriotomy is spaced apart from the locationon the target vessel at which the anvil arm 14 is inserted, because thecutter 200 and the projection 208 have moved proximally a selecteddistance before penetrating or incising the wall of the target vessel.The portion of the wall of the target vessel between the arteriotomy andthe insertion point of the anvil arm 14 may be referred to as a tissuebridge. The incision is referred to as an arteriotomy for convenience,and this terminology does not limit the type of anastomosis that may beperformed. For example, anastomosis may be performed between two tissuestructures that are not blood vessels, such as bile ducts.

The projection 208 of the cutter 200 enters the wall of the targetvessel at a location between the arms 402 of the staple holder 38. Eacharm 402 holds at least a portion of a flap 408 of the graft vessel 404against the wall of the target vessel, such that the projection 208enters the wall of the target vessel at a location between the flaps408. The length of the cutter 200, the position of the projection 208 onthe cutter 200, and the placement of the first lower opening 254 may beselected such that the projection 208 enters the wall of the targetvessel after at least one staple 446 is deployed into one of the flaps408 and the wall of the target vessel. Alternately, the projection 208enters the wall of the target vessel before any of the staples 446 havebeen deployed, or after all of the staples 446 have been deployed.Further, the length of the cutter 200, the position of the projection208 on the cutter 200, and the placement of the first lower opening 254may be selected such that the projection enters the wall of the targetvessel at substantially the same time that one or more vein knives 432begin to incise the corresponding flaps 408.

As the sled 482 continues to advance distally, the distal end 474 ofeach ramp element 476 actuates each connector deployer 452 in turn,causing the sliders 452 to sequentially deploy the corresponding staples446 as described above. Additionally, the vein knives 432 continue tomove distally as the sled 482 advances distally, lengthening theincision in the root 405 of each flap 408. Further, referring also toFIG. 47, the cutter 200 continues to advance distally as the receiver218 continues to urge the engagement feature 216 distally. The cutter200 incises the wall of the target vessel at a given longitudinalposition at substantially the same time as each vein knife 432 incisesthe corresponding flap 408 at the that longitudinal position.Alternately, the timing of the cutting action of the cutter 200 and thevein knives 432 is different, such that the cutter 200 incises the wallof the target vessel at a given longitudinal position either before orafter each vein knife 432 incises the corresponding flap 408 at thatlongitudinal position.

The lower surface of the keel 264 contacts the bottom surface 266 of thechannel 246 during this translation. The contact between the keel 264and the bottom surface 266 of the channel 246 counteracts the downwardbias of the distal end of the cutter 200. In this way, the projection208 is maintained above the contact surface 206 of the anvil arm 14. Asthe cutter 200 continues to translate distally, the projection 208 movesthrough the tissue of the wall of the target vessel in a directionsubstantially parallel to the longitudinal centerline of the anvil arm14, and incises the tissue of the wall of the target vessel to create anarteriotomy. Because the projection 208 is connected to and translatedby the cutter 200, which is within the target vessel, the arteriotomy isperformed from within the target vessel. The tip of the projection 208may maintain substantially the same height relative to the contactsurface 206 of the anvil arm 14 during translation of the cutter 200, ormay change its height relative to the contact surface 206 of the anvilarm, as long as the projection 208 continues to incise completelythrough the wall of the target vessel.

Where the cutter of FIG. 43B is used, the lower surface of the secondkeel 265 and the lower surface of the first keel 264 both contact thebottom surface 266 of the channel 246. Alternately, the lower surface ofthe first keel 264 extends downward enough that the lower surface of thesecond keel 265 does not contact the bottom surface 266 of the channel246.

Referring also to FIG. 48, a second lower opening 268 is defined throughthe lower surface 256 of the anvil arm 14. The second lower opening 268is distal to and substantially aligned with the first lower opening 254.The cutter 200 continues to advance distally as the receiver 218continues to impel the engagement feature 216 distally. As a result ofthis translation, the keel 264 encounters the proximal end of the secondlower opening 268. Because the distal end of the cutter 200 is biaseddownward, the keel 264 moves downward at least partially into the secondlower opening 268. The downward motion of the keel 264 causes the distalend of the cutter 200 and the projection 208 to move downward. The keel264 and/or the proximal end of the second lower opening 268 may beconstructed to provide a smooth, gradual downward motion of the keel264, such as by providing a gradual slope on the keel 264 and/or theproximal end of the second lower opening 268. Alternately, the keel 264and/or the proximal end of the second lower opening 268 may beconstructed to allow or cause the keel 264 to move downward abruptlyupon encountering the proximal end of the second lower opening 268.Alternately, where the cutter 200 of FIG. 43B is used, the first keel264 moves as least partially into the third lower opening 269, and thesecond keel 264 moves at least partially into the second lower opening268. The downward motion of the distal end of the cutter 200 causes theprojection 208 to retract into or completely through the upper opening248, such that the projection 208 no longer encounters the tissue of thewall of the target vessel. The projection 208 may be urged downwardcompletely into the channel 246, depending on the depth of the channel246 and the height of the projection 208.

Alternately, the upper tip of the projection 208 may remain within theupper opening 248. The cutter 200 may stop its distal translation atsubstantially the same time that the projection 208 retracts completelyinto the upper opening 248, or may continue to translate distally withinthe channel 246 before coming to a stop. Alternately, the second loweropening 268 is not provided, and only the first lower opening 254extends through the lower surface 156 of the anvil arm 14 into thechannel 246. In such a configuration, the cutter 200 is retracted in theproximal direction after the arteriotomy is formed, until the keel 264moves downward into the first lower opening 254 and the projection 208consequently retracts completely into the upper opening 248.

The sled 482 continues to move distally, such that the distal end 474 ofthe ramp element 446 actuates the most distal connector deployer 452 anddeploys the corresponding staple 446. Referring also to FIG. 76, theconnection between the end of the graft vessel 404 and the target vessel580 is then complete. The sled 482 continues to translate, such thateach vein knife 432 then moves completely through the corresponding flap408. A portion of each flap 408 continues to be held between each graftclip 412 and corresponding flap receiving surface 406. Thus, when theroot 405 of each flap 408 has been completely incised through by thecorresponding vein knife 432, the staple holder 38 no longer holds thegraft vessel 404, and is freed from the anastomosis site.

Referring to FIG. 73, the rocker 508 completes its travel when thedistal end 520 of the distal arm 516 contacts one or more of the ribs556 in the handle 302. This contact prevents further downward motion ofthe distal arm 518, and thereby causes the rocker 508 to cease itsmotion. Alternately, at least a portion of the distal arm 516 and/or theproximal arm 514 contact a stop or other structure in the handle 302which obstructs further motion of the rocker 508. Alternately, themotion of the rocker 508 is stopped in a different way, such as by abraking or clutch mechanism. Thus, the corresponding travel of thesecond cable 490 and the connected sled 482 cease as well. After therocker 508 has completed its travel, the upper portion 532 of thecontact feature 528 of the proximal slider 522 contacts the proximal end516 of the proximal arm 514. The spring 546 biases the proximal slider522 distally. Thus, the upper portion 532 of the contact feature 528 ispressed against the proximal end 516 of the proximal arm 514, holdingthe proximal arm 514 and the rocker 508 in place and substantiallypreventing rotation of the rocker 508 in a direction opposite to itsprevious motion. Alternately, the proximal slider 522 does not contactthe rocker 508 after the travel of the rocker 508 is complete. Atsubstantially the same time as the motion of the rocker 508 stops, thelower guide 552 of the distal slider 534 contacts a stop 553 defined inor connected to the handle 302. The stop 553 may be integrated with atleast one of the ribs 556. The stop 553 is positioned to interfere withfurther proximal motion of the distal slider 534, such that contactbetween the lower guide 552 and the stop 553 causes the distal slider534 to cease moving proximally. Alternately, the stop 553 is not used,and the distal slider 534 is allowed to continue to move proximallyafter deployment of the staples 446. Referring also to FIG. 77, this istime t=4, at which the distal slider 534 has moved proximally from itsposition at time t=3, and the proximal slider has moved slightlydistally from its position at time t=3.

As described above, the distal slider 534 may include a verificationstub 560 that extends substantially upward from the upper end of thedistal slider 534 through a slot 562 in the handle 302. Initially, whenthe distal slider 534 is in its most distal position, the verificationstub 560 is also in its most distal position. As the distal slider 534translates proximally during actuation of the anastomosis tool 300, theverification stub 560 also translates proximally. Thus, after theanastomosis tool 300 has been actuated and the distal slider 534 hasmoved to its most proximal position, the verification stub 560 has movedto its most proximal position as well. By visually inspecting theposition of the verification stub 560, the user can confirm whether theanastomosis tool 300 has been completely actuated. In addition, thedistal end 474 of at least one ramp element 446 may be visible afteractuation of the anastomosis tool 300 if the distal end 442 of thepassage 440 is open, providing another visual indication that theanastomosis tool 300 has been completely actuated. The distal end of thefirst lower opening 254 and the proximal end of the second lower opening268 control the motion of the projection 208 and thereby control thepenetration of the wall of the target vessel. That is, the distancebetween the distal end of the first lower opening 254 and the proximalend of the second lower opening 268 determines the length of thearteriotomy.

Alternately, where the snap arm 606 is used instead of the cam lock tohold a corresponding graft clip 412 in the closed position, the distalend 474 of the corresponding ramp element 446 extends out of the distalend 442 of the passage 440 to disengage the catch 608 of the snap arm606. That is, the lobe 610 of the snap arm 606 is positioned relative tothe distal end 442 of the passage 440 such that the distal end 474 ofthe corresponding ramp element 446 encounters the lobe 610 near the endof the travel of the ramp element, pushing the lobe 610 out ofengagement of the arm 402 and thus disengaging the catch 608 from thearm 402. The corresponding graft clip 412 is thereby free to move out ofthe closed position, freeing the flap 408 held by that graft clip 412.In such an embodiment, the vein knives 432 may be omitted, because theflaps 408 are freed in their entirety. Further, the spikes 410 areomitted, such that the flaps 408 are not held in place on the flapreceiving surface 406 after the snap arm 606 is disengaged from the arm402.

After performing the arteriotomy, the cutter 200 is in adistally-extended position. The cutter 200 remains in that position asthe anvil arm 14 is removed from the target vessel 580, where the tissuebridge 582 separates the anastomosis site from the hole 584 in the wallof the target vessel 580 through which the anvil arm 14 entered thetarget vessel 580. Thus, the projection 208 does not extend out of theupper opening 248 during removal of the anvil arm 14 from the targetvessel 580. Alternately, after performing the arteriotomy, the cutter200 may be moved proximally within the channel 246 in the anvil arm 14before removing the anvil arm 14 from the target vessel 580.

The tissue effector 400 is then returned to the open position from theclosed position, to allow the anvil arm 14 to be withdrawn from thetarget vessel 580. After the trigger 308 has been depressed to deployone or more connectors 464, the distal arm 518 of the rocker 508 hasdeflected at least a portion of the holder 594. As a result, thedeflected holder 594 exerts an opposing bias against the distal arm 518of the rocker 508. When the user releases the trigger 308, the biasedholder 594 then acts against the distal arm 518, pushing it upward andcausing the rocker 508 to rotate about the rocker axle 510. As a result,the proximal arm 514 of the rocker 508 moves downward toward itsoriginal position. Thus, the proximal end 516 of the proximal arm 514moves downward against the upper portion 532 of the contact feature 528of the proximal slider 522, and continues to move downward past theintersection between the two portions 530, 532 of the contact feature528. As the proximal end 516 of the proximal arm 514 moves past thatintersection to contact the lower portion 530 of the contact feature528, the proximal slider 522 is freed to move distally a small amountdue to the bias of the spring 546. This proximal motion relaxes thetension on the first cable 480. As a result, the biasing element 475pushes the staple holder 38 away from the anvil 10, returning the tissueeffector 400 to the open position. The tissue effector 400 thus nolonger clamps the wall of the target vessel 580, and the anvil arm 14can be removed from the lumen of the target vessel 580. The spacingbetween the staple holder 38 and the anvil 10 in the open position isselected to ensure adequate clearance for separation of the tissueeffector 400 from the target vessel 580. For example, the staple holder38 is moved far enough from the anvil 10 such that the spikes 410 arefully removed from the flaps 408 before the anvil arm 14 is removed fromthe target vessel 580. Alternately, the tissue effector 400 is returnedto the open position in another manner. When the projection 208 isretracted out of the tissue of the wall of the target vessel, the distalend of the arteriotomy is defined, and the arteriotomy is complete.Thus, the anastomosis is complete as well.

Referring also to FIG. 74, the completed anastomosis between the graftvessel 404 and the target vessel 580 remains. The hole 584 in the wallof the target vessel 580 through which the anvil arm 14 entered thetarget vessel 580 is small enough to prevent significant bleedingthrough the puncture site after the anvil arm 14 has been withdrawn.Alternately, the hole 584 is closed by hand suturing. Alternately, thehole 584 is closed with a biocompatible glue, adhesive or the like.Alternately, the hole 584 is closed with a clip, clamp, or otherimplantable device that remains on the target vessel. Such a device maybe positioned on the outer surface and/or inner surface of the targetvessel, and may extend into the hole 584. A device for closing the hole584 may be constructed from nitinol or other superelastic orpseudoelastic material, or from stainless steel or other material, wherethat device moves between a first configuration and a secondconfiguration during deployment, and where the second configurationholds the hole 584 closed. The hole 584 is less than substantially 2 mmwide, and advantageously less than 1 mm wide.

As described above, the cutter 200 incises the wall of the target vesselwhile the staple holder 38 is stapling or otherwise connecting the graftvessel to the target vessel, as described in greater detail below.Alternately, the staple holder 38 may completely staple or otherwiseconnect the graft vessel to the target vessel before the cutter 200 isurged forward, such that the two vessels are connected before the cutter200 makes an incision between them. Alternately, the cutter 200 incisesthe wall of the target vessel before the staple holder 38 has stapled orotherwise connected the graft vessel to the target vessel.

Referring to FIG. 49, a different embodiment of the anvil 10 alsoincludes a cutter 200 moveable relative to the anvil 10 for making anincision in the wall of a target vessel. The anvil 10, anvil arm 14,staple holder 38, and other components are substantially as describedabove with regard to FIGS. 34-38 and 44-49. In this embodiment, at leastthe distal end of the cutter 200 is biased upward. In other regards, theactuation of the anastomosis tool 300, the operation of the mechanismswithin the handle 302, and the operation of the tissue effector 400 aresubstantially as described above. Referring to FIGS. 35 and 49, theanvil insert 222 is connected to the anvil 10. An aperture 230 isdefined through the distal end of the anvil insert 222 into the cavity228 defined within the anvil insert 222, connecting the channel 246 tothe cavity 228. The cutter 200 extends through the aperture 230 in theanvil insert 222, such that the distal end of the cutter 200 ispositioned within the channel 246 and the proximal end of the cutter 200is positioned within the cavity 228. A cam 232 is positioned within thecavity 228 above the aperture 230. Alternately, the cam 232 may bepositioned differently relative to the aperture 230. The cam 232 is astructure used in controlling the motion of the cutter 200, as isdescribed in greater detail below.

At least the distal end of the cutter 200 may be biased upward. Thisbiasing may be performed by any appropriate structure or mechanism, suchas by one or more springs (not shown). Such a spring or springs may actin compression to push the distal end of the cutter 200 upward, or mayact in tension to pull the distal end of the cutter upward. As anotherexample, the cutter 200 may be constructed from an elastic orsuperelastic material that is formed in such a way as to produce anupward bias. The entire cutter 200 may be biased upward, if desired. Atleast the distal end of the cutter 200 is biased upward during thetranslation of the cutter 200 along the anvil arm 14. Alternately, thecutter 200 is not biased, either upward or downward. Instead, the cutter200 is urged upward and downward at different locations during itstranslation by the interaction between at least one cam follower on thecutter 200 and at least the cam 232.

As shown in FIG. 49, the distal end of the anvil arm 14 is spaced apartfrom the staple holder 38. The anvil arm 14 is inserted through the wallof the target vessel, as described above, such that the contact surface206 of the anvil arm 14 is in substantial contact with the inner wall ofthe target vessel. Next, referring to FIG. 50, the staple holder 38 andanvil 10 are moved relative to one another into the standby position, asdescribed above. In the standby position, the cutter 200 is freed fortranslation along the channel 246, because the tip 212 of the safetyfeature 210 no longer engages the safety recess 214 of the cutter 200.At least the distal end of the cutter 200 is biased upward, and the cam232 limits the upward motion of the cutter 200 by contacting at least aportion of the upper surface 252 of the cutter 200. The cam 232 controlsthe motion of the distal end of the cutter 200 in the vertical directionas the cutter 200 translates within the channel 246. Because theprojection 208 is fixed to the cutter 200, the cam 232 also controls themotion of the projection 208 in the vertical direction, and thuscontrols the location at which the projection 208 encounters the wall ofthe target vessel.

Referring also to FIG. 51, after the cutter 200 has been freed fortranslation, it is urged distally by the receiver 218 as describedabove. A first cam follower 242 is defined on the upper surface 252 ofthe cutter 200. The first cam follower 242 is a raised structure formedinto the upper surface 252 of the cutter 200. Alternately, the first camfollower 242 is a separate structure or mechanism constructed separatelyfrom the cutter 200 and later connected to the cutter 200. Alternately,the first cam follower 242 may be located on a surface of the cutter 200in addition to or instead of its upper surface 252, depending on theposition and configuration of the cam 232. The first cam follower 242may be shaped as a trapezoid or similar shape, or may be shapeddifferently.

The cam 232 is fixed, and the first cam follower 242 is raised relativeto the upper surface 252 of the cutter 200. At least the distal end ofthe cutter 200 is biased upward. Thus, as the cutter 200 translatesdistally, the cam 232 engages the first cam follower 242 and causes thecutter 200 to move downward. The cam 232 and the first cam follower 242are shaped to smoothly engage each other. Alternately, the first camfollower 242 is shaped to induce the cutter 200 to abruptly movedownward when the first cam follower 242 initially encounters the cam232. The height of the first cam follower 242 relative to the contactsurface 206 of the anvil arm 14 determines the distance that the distalend of the cutter 200 is moved downward. As described above, the cutter200 may include a keel 264 or similar projection extending downward. Asthe distal end of the cutter 200 moves downward, the keel 264 or otherprojection moves into the first lower opening 254. In this embodiment,the first lower opening 254 does not control the motion of the cutter200; instead, it provides a space for the keel 264 to move downwardwithout interfering with the vertical motion of the distal end of thecutter 200. If the keel 264 is omitted, the first lower opening 254 andthe second lower opening 268 may be omitted as well.

The connection between the graft vessel and the target vesselsubstantially defines a closed area, and the projection 208 isconfigured to engage the wall of the target vessel within that closedarea. That is, the end of the graft vessel has a perimeter that contactsthe side of the target vessel, such that the perimeter of the end of thegraft vessel defines a closed area on the wall of the target vessel. Inthis way, the projection 208 makes an incision completely within theconnection between the graft vessel and the target vessel, completingthe anastomosis between the two vessels and minimizing or eliminatingleakage at the anastomosis site. While the projection 208 on the cutter200 remains below the contact surface 206 of the anvil arm 14, itneither engages nor cuts the wall of the target vessel. Thus, the firstcam follower 242 is sized to translate the tip of the projection 208below the contact surface 206 of the anvil arm 14 for a selecteddistance such that the projection 208 does not engage the tissue of thetarget vessel until the projection 208 is positioned to enter the closedarea on the wall of the target vessel defined by the perimeter of theend of the graft vessel.

Referring also to FIG. 52, the cutter 200 continues to advance distallyas the receiver 218 continues to impel the engagement feature 216distally. Thus, the first cam follower 242 of the cutter 200 advancesdistally relative to the cam 232. As described above, at least thedistal end of the cutter 200 is biased upward. The first cam follower242 decreases in height at its proximal end. Thus, as theupwardly-biased first cam follower 242 moves distally relative to thecam 232, the cam 232 and the first cam follower 242 gradually disengage,causing both the distal end of the cutter 200 and the projection 208 tomove upward. The first cam follower 242 is constructed to provide asmooth, gradual upward motion of the distal end of the cutter 200 andthe projection 208, such as by providing a gradual slope between anupper surface 250 of the first cam follower 242 and an upper surface 252of the cutter 200. Alternately, the first cam follower 242 may beconstructed to allow the distal end of the cutter 200 and the projection208 to abruptly snap upward as the first cam follower 242 moves distalto the cam 232.

As the distal end of the cutter 200 moves upward, the projection 208moves upward through the upper opening 248 in the anvil arm 14. Thecontact surface 206 of the anvil arm 14 is adjacent to the inner surfaceof the wall of the target vessel. Thus, upward motion of the projection208 through the upper opening 248 causes the projection 208 to enter thewall of the target vessel. The projection 208 is sized, and the firstcam follower 242 and cam 232 are shaped, such that the upward motion ofthe projection 208 after the first cam follower 242 has moved distal tothe cam 232 causes the projection 208 to completely penetrate throughthe wall of the target vessel. That is, at least a portion of theprojection 208 passes through the wall of the target vessel and entersthe lumen. This initial penetration of the wall of the target vesseldefines the starting point of an arteriotomy performed on the targetvessel by the projection 208. The starting point of the arteriotomy isspaced apart from the location on the target vessel at which the anvilarm 14 is inserted, resulting in a tissue bridge therebetween.

Referring also to FIG. 53, the cutter 200 continues to advance distallyas the receiver 218 continues to impel the engagement feature 216distally. The upper surface 252 of the cutter 200 may contact the cam232 during this motion, because the distal end of the cutter 200continues to be biased upward. As the cutter 200 translates, theprojection 208 moves through the tissue of the wall of the target vesselin a direction substantially parallel to the longitudinal centerline ofthe anvil arm 14. In this way, the projection 208 incises the tissue ofthe wall of the target vessel to create an arteriotomy. The tip of theprojection 208 may maintain substantially the same height relative tothe contact surface 206 of the anvil arm 14 during its distaltranslation, or may change its height relative to the contact surface206 of the anvil arm 14, as long as the tip of the projection 208remains in the lumen of the target vessel during that translation.

Referring also to FIG. 54, a second cam follower 244 is defined on theupper surface 252 of the cutter 200, proximal to and spaced apart fromthe first cam follower 242. Alternately, a single cam follower isdefined on the upper surface 252 of the cutter 200, where that singlecam follower includes a feature corresponding to the first cam follower242, a feature corresponding to the second cam follower 244, and asection of reduced height between them corresponding to the uppersurface 252 of the cutter 200. The cutter 200 continues to advancedistally as the receiver 218 continues to impel the engagement feature216 distally. As a result of this motion, the second cam follower 244contacts the cam 232. Engagement between the second cam follower 244 andthe cam 232 pushes the distal end of the cutter 200 downward. The shapeand size of the second cam follower 244 and cam 232 are selected suchthat the distal end of the cutter 200 is pushed downward far enough tocause the projection 208 to retract into the upper opening 248. Theprojection 208 may be urged downward completely into the channel 246,depending on the depth of the channel 246 and the height of theprojection 208. Alternately, the upper tip of the projection 208 mayremain within the upper opening 248. The cutter 200 may stop its distaltranslation at substantially the same time that the projection 208retracts completely into the upper opening 248, or may continue totranslate distally within the channel 246 before coming to a stop.

When the projection 208 is retracted out of the tissue of the wall ofthe target vessel, the distal end of the arteriotomy is defined, and thearteriotomy is complete. The distance between the first cam follower 242and the second cam follower 244, and the shape of the cam followers 242,244, determine the length of the arteriotomy. That is, each cam follower242, 244 includes a location thereon having a height relative to theupper surface 252 of the cutter 200 sufficient to cause the projection208 to be pushed out of contact with the wall of the target vessel. Thedistance between these locations defines the length of the arteriotomy.Thus, the cam followers 242, 244 control the motion of the projection208 and control the penetration of the wall of the target vessel.

After performing the arteriotomy, the cutter 200 is in adistally-extended position. The cutter 200 remains in that position asthe anvil arm 14 is removed from the target vessel. Alternately, afterperforming the arteriotomy, the cutter 200 may be moved proximallywithin the channel 246 before removing the anvil arm 14 from the targetvessel. The anvil arm 14 is removed from the target vessel after theanastomosis between the graft vessel and the target vessel has beencompleted. The hole at the puncture site and its closure aresubstantially as described above.

Alternately, the cutter 200 is initially in a distally-extendedposition, and retracted proximally in order to make an incision in thewall of the target vessel. Similarly, the sled 482 is initially at itsmost distal location. The structures and mechanisms are substantially asdescribed above, but operated in substantially the reverse order asdescribed above. In this embodiment, the channels 496 in the stapleholder 38 are not needed, nor it is necessary to reverse the directionof motion of the second cable 490 as applied to the sled 482; rather,the sled 482 is deployed by pulling it proximally with the second cable490. Thus, the second cable 490 may be connected to the proximal end orother portion of the sled 482. Alternately, the cutter 200 and theprojection 208 may be moved in a different way in order to incise thetissue of the wall of the target vessel. Further, this embodiment isparticularly suited for the use of a cutter 200 having a sharp distalend that initially extends out of the distal end of the anvil arm 14 inorder to puncture the target vessel, after which the cutter 200 isretracted proximally to move its sharp distal end into the anvil arm 14.

Where multiple projections 208 are provided on the cutter 200 as shownin FIGS. 39-43, the cutter 200 need not be translated as far to make anincision in the wall of the target vessel as it would if only a singleprojection were used. Because the projections 208 are spaced apart fromeach other along the direction of translation of the cutter 200, eachprojection 208 is able to form a portion of the incision duringtranslation of the cutter 200. Thus, by translating each projection 208across a distance less then the intended length of the entire incision,the complete incision can be formed. The distance that the cutter 200 istranslated to form the incision is related to the distance between theprojections 208. That is, because each projection 208 forms a portion ofthe incision, no single projection 208 need be translated along theentire length of the incision.

Alternately, where multiple projections 208 are utilized, theprojections 208 may be inserted into the wall of the target vessel,after which energy is applied to the projections 208 via the cutter 200or directly in order to create an incision in the wall of the targetvessel. In such an embodiment, an energy source (not shown) is connectedto the cutter 200. For example, an ultrasound generator (not shown) maybe connected to the cutter 200 and to the energy source. The ultrasoundgenerator may be a piezoelectric crystal, as is standard, or a differentstructure or mechanism. Electrical energy may be applied to theultrasound generator from the energy source, thereby causing theultrasound generator to vibrate the projections 208. Thus, energy may beapplied from the energy source to the ultrasound generator after theprojections 208 have been inserted into the wall of the target vessel,causing the projections 208 to move and thereby create an incision.Advantageously, a plurality of projections 208 spaced relatively closeto one another are utilized. Other methods may be used to vibrate, moveor oscillate the projections 208.

Alternately, the length of the arteriotomy created by and the number ofconnectors 464 deployed by the tissue effector 400 are adjustable. Bycontrolling these parameters, graft vessels of different diameters canbe attached to a target vessel within a small range of angles relativeto the graft vessel. The cross-sectional area of the connection betweenthe graft vessel and the target vessel thus can be controlled across arange of two or more sizes while providing for a substantially fixedangle between the target vessel and the graft vessel.

The number of connectors 464 deployed by the tissue effector 400 can becontrolled in any appropriate manner. As one example, by varying thestroke of the sled 482 and therefore the length along each passage 440that is traversed by the corresponding ramp element 446 of the sled 482,the number of connectors 464 deployed as a result of motion of the sled482 can be controlled. Control of the stroke of the sled 482 may beaccomplished in any appropriate manner. For example, a control (notshown) connected to the handle 302 may allow the selection of aparticular number of connectors 464 for deployment. Such a control mayinteract with the second cable 490 and/or other components of orconnected to the handle 302, in order to restrict the length that thesecond cable 490 moves upon actuation. By restricting the motion of thesecond cable 490, the stroke of the sled 482 is controlled, and hencethe number of connectors 464 deployed is controlled. As another example,a set of controllable stops (not shown) may be provided within thetissue effector 400. Each stop is positioned in proximity to a connectorbay 448, and is moveable between a first position that is out of thepassage 440 adjacent to the connector bay 448 and a second position thatis at least partially into the passage 440. In the second position, thestop contacts and prevents further distal motion of the correspondingramp element 446 of the sled 482. The control interacts with the stops,such that when the control is used to select a particular number ofconnectors 464 for deployment, at least one stop is moved to its secondposition into a passage 440 of the tissue effector 400. Each stop thatis moved to its second position corresponds to the connector bay 448from which the last of the selected number of connectors 464 is to bedeployed. Other mechanisms, structures or methods may be used to controlthe number of connectors 464 that are deployed.

Similarly, the length of the arteriotomy is controlled to correspond tothe length of tissue that is connected by the selected number ofconnectors 464. The length of the arteriotomy can be controlled bycontrolling the motion of the cutter 200. The motion of the cutter 200can be controlled in several ways. As one example, the openings 254, 268in the anvil arm 14 can be changed both in length and position, toensure that the arteriotomy is made to the correct length in the correctposition. The openings 254, 268 can be changed in length and position inany appropriate manner. As one example, one or more pins or otherstructures (not shown) are extendable laterally across the openings 254,268, such that the presence of those pins or other structures across theopenings 254, 268 effectively changes their length and position. Othermechanisms, structures or methods may be used to control the length andposition of the openings 254, 268 and/or the motion of the cutter 200.

FIGS. 17-23 illustrate an alternate anvil 100 that is used with a clamp,102 for controlling an incision site during an anastomosis procedure. Asshown in FIGS. 17 and 18, the anvil 100 includes an anvil arm 104 and ahandle 106. The clamp 102 is slidable on the handle 106 to clamp thetissue of the target vessel 30 between the clamp 102 and the anvil arm104. As with the anvil arm 104 described above, the anvil arm 104includes two rows of staple bending features 108 in the form of recessespositioned in two parallel rows along a top surface of the anvil arm104. The clamp 102 has a central opening 110. Once the tissue of thetarget vessel wall has been trapped between the clamp 102 and the anvilarm 104, an incision may be made through the target vessel wall and theedges of the incision are controlled by the combination of the anvil arm104 and the clamp 102.

As shown in FIG. 19, a continuous anastomosis staple device 114 may beused to connect the graft vessel 32 to the target vessel 30 at theanastomosis site. The staple device 114 as shown in FIG. 19 includes aplurality of linkages forming a tubular configuration and a plurality ofstaple ends extending from the linkages. FIGS. 20-22 illustrate how thestaple ends 116 of the staple device 114 are positioned in the end ofthe graft vessel 32 and are inserted through the incision 118 in thetarget vessel and bent over by contact with the staple bending features108 of the anvil. As shown in FIG. 22, the opposite ends 120 of thestaple device 114 are folded over to complete the anastomosis. FIG. 23illustrates a completed anastomosis performed according to the stepsillustrated in FIGS. 19-22.

FIGS. 24-27 illustrate an alternate example of an anvil arm 14 d havinga cutting wire 124 for forming the incision in the wall of the targetvessel 30. The cutting wire 124 may be used to form an incision before,during or after performing an end-to-side anastomosis procedure.Referring particularly to FIGS. 26-27, for forming the incision afterthe anastomosis procedure, a clamp 126 is used to trap the tissue at theanastomosis site between the clamp 126 and the anvil arm 14 d prior toperforming the incision. The incision is spaced apart from the entrypoint of the anvil arm 14 d into the target vessel, creating a tissuebridge between the incision made in the wall of the target vessel andthe entry point of the anvil arm 14 d into the target vessel. A portionof the contact between the anastomosed graft vessel and target vesselextends across the tissue bridge, such that the incision is locatedwithin the closed area defined by the contact between the perimeter ofthe end of the graft vessel and the wall of the target vessel.

FIG. 28 shows a system 140 for controlling a tissue site and performinganastomosis. For purposes of clarity, the staple holder and staples havebeen omitted from FIG. 28. The system 140 includes an anvil arm 142, acutter 144, and a graft vessel holder 146 all mounted on a handle 148.The anvil arm 142 is mounted on the handle 148 and connected to a firstactuator 150 that allows the anvil to be moved downward against the biasof a spring inside the handle. The cutter 144 may be spring biased orfixed and is positioned on the handle 148 directly above the anvil arm142. The graft vessel holder 146 includes two fixed arms 152 and twomovable arms 154. The two movable arms 154 are connected to a secondactuator 156 on the handle 148. Depression of the second actuator 156against the bias of a spring within the handle causes the movable arms154 to be moved downward away from the fixed arms to receive portions ofa graft vessel between the movable and fixed arms.

The operation of the system 140 of FIG. 28 is shown in the crosssectional views of FIGS. 29-31. As shown in FIG. 29, an end of a graftvessel 32 is split so that each half of the graft vessel 32 can be heldbetween a fixed arm 152 and a movable arm 154. In order to load thegraft vessel 32 into the system 140, the first actuator 150 and thesecond actuator 156 are depressed to move the anvil arm 142 and themovable arms 154 downward. The split graft vessel 32 is then insertedbetween the fixed and movable arms 152, 154 and the second actuator 156is released to trap the ends of the graft vessel 32, as shown in FIG.30. The anvil arm 142 is then inserted into the target vessel 30 in thesame or similar manner as described above.

Once the anvil has been inserted in the target vessel 30 as shown inFIG. 30, the first actuator 150 is released to allow the anvil to moveupward to tent the wall of the target vessel. FIG. 31 illustrates thetented target vessel 30 positioned adjacent the split and trapped graftvessel 32 in a position for performing anastomosis. The staple holders38 are then advanced in the direction of the arrows D toward oppositesides of the anvil to staple the graft vessel and target vesseltogether. The staple holders 38 may hold a staple strip with anexpandable backbone as shown in FIGS. 10A and 10B, or may instead oradditionally hold different types of staples not connected to abackbone. The staple holders 38 may be provided with movable pins whichallow the spacing between the staples to be adjusted depending on a sizeof the graft vessel used. Once the staples have been placed, the anvilarm 142 is removed and the cutter 144 makes an incision in the targetvessel before or during removal of the anvil.

As described above, staple bending features are provided on the anviland staples are provided at an exterior of the tissue. Alternately, thestaples and/or staple holding strips may be positioned on the anvil andan exterior member with staple bending features may be moved toward theanvil to bend the ends of the staples and secure the graft and targetvessels together.

FIGS. 32-33 illustrate the use of an alternate anvil 130 for controllingthe tissue at an anastomosis site. The anvil 130 includes a longitudinalopening 132 extending through the anvil 130 for application of aplurality of conventional sutures at the anastomosis site. According tothis method, the anvil 130 is inserted into the target vessel 30 andpulled against the interior wall of the target vessel 30, tenting thetarget vessel as shown in FIG. 33. Sutures 134 are then passed throughthe opening 132 in the anvil 130 and through the tissue of the targetvessel wall on opposite sides of the anvil 130. Once the sutures 134 areplaced as shown in FIG. 33, an incision is made in the target vesselalong a center of the anvil 130. A center portion of each of the sutures34 is then pulled out through the incision in the target vessel and cutso that an even row of sutures is provided along each of the sides ofthe incision. This system eliminates the tedious procedure of placingeach individual suture very close to the edge of the incision in thevery thin and flexible target vessel wall. Each of the sutures 134 isconnected to a graft vessel in a conventional manner completing theanastomosis. The anvil as shown in FIGS. 32-33 allows quick and easyplacement of a plurality of sutures in a very even manner close to theedge of the incision. For example, the sutures of a conventionalanastomosis are generally within about one millimeter of the edge of theincision and are advantageously within 0.5 millimeters of the edge ofthe incision.

In an alternate embodiment, the cutter 200 does not include one or moreprojections 208. Instead, the cutter 200 includes or is connecteddirectly or indirectly to an energy source (not shown), which is used tocreate an opening in the wall of the target vessel. For example, anemitter of laser or RF energy, or another type of energy, may beconnected to the cutter 200 and to the energy source. As the cutter 200translates along the anvil arm 14, it translates the emitter of laser orRF energy relative to the wall of the target vessel. The emitter oflaser or RF energy is selectively actuated to transmit energy into thewall of the target vessel during translation of the cutter 200, therebycreating an opening therein. The energy source may transmit a first typeof energy to the emitter or other mechanism, which is converted by theemitter into a second type of energy delivered into the wall of thetarget vessel. Alternately, the cutter 200 may include a projection 208and additionally be connected to an energy source that is selectivelyactuated in order to assist in creating an opening in the wall of thetarget vessel.

In an alternate embodiment, the cutter 200 does not translate throughthe anvil arm 14. Instead, the cutter 200 is spatially removed from theanvil arm 14, and creates an opening in the wall of the target vesselbefore or after the anvil arm 14 is inserted into the target vessel. Inone example of such an embodiment, the anvil arm 14 is inserted into ahole in the wall of the target vessel and the staple holder 38 deploysstaples or other connectors to connect the graft vessel to the targetvessel, as described above. The anvil arm 14 is removed, and anindependent cutter 200 is then introduced through the hole in the wallof the target vessel. The cutter 200 may be configured as describedabove, including a projection 208 extending therefrom, or may beconfigured differently. The cutter 200 is manipulated relative to theconnection between the target vessel and the graft vessel to create anopening at the junction therebetween. That is, registration ismaintained between the cutter 200 and the junction between the end ofthe graft vessel and the wall of the target vessel. In order to positionand manipulate the cutter 200 to create an opening at the location ofthe junction between the target vessel and the graft vessel, an imagingdevice (not shown) or other device may be connected to the cutter 200 orutilized in conjunction with the cutter 200. For example, a standardintravascular ultrasound unit may be connected to or used in conjunctionwith the cutter 200. The intravascular ultrasound unit is connected to adisplay device (not shown) visible to the operator. The operatorcontrols the intravascular ultrasound unit to visualize the interior ofthe target vessel and the surrounding area, thereby locating thejunction between the target vessel and the graft vessel and allowing thecutter 200 to be controlled to incise an opening in the wall of thetarget vessel within the closed area on the wall of the target vesseldefined by the perimeter of the end of the graft vessel, therebyallowing blood to flow through the opening into the target vessel. Adifferent visualization device or devices may be inserted into orpositioned outside of the target vessel to locate the junction with thegraft vessel. The cutter 200 and any visualization device present in thelumen of the target vessel are then removed from the lumen of the targetvessel, and the opening in the wall of the target vessel through whichthey were removed is sealed.

In another example of such an embodiment, the anvil arm 14 is insertedinto a hole in the wall of the target vessel and the staple holder 38deploys staples or other connectors to connect the graft vessel to thetarget vessel, as described above. The anvil arm 14 is removed, and thehole in the wall of the target vessel is removed. A cannula (not shown)is inserted into the lumen of the graft vessel through the free end ofthe graft vessel, and a stylet (not shown) is inserted through the lumenof the cannula. The cannula and the stylet are surgical instruments thatare well known in the art. The stylet has a distal end configured topenetrate the wall of the target vessel. Thus, a sharp point, blade, orother penetrating member may be formed into or connected to the distalend of the stylet. The cannula may be inserted into the lumen of thegraft vessel such that its distal end contacts the outer wall of thetarget vessel. After the stylet has been inserted into the cannula, aforce is exerted on the stylet to cause its distal end to penetrate thewall of the target vessel. Consequently, an opening is created betweenthe graft vessel and the target vessel within the circumference of theend of the graft vessel. The cannula and stylet are then removed fromthe lumen of the graft vessel through its free end.

In another example of such an embodiment, the anvil arm 14 is insertedinto a hole in the wall of the target vessel and the staple holder 38deploys staples or other connectors to connect the graft vessel to thetarget vessel, as described above. The anvil arm 14 is removed, and thehole in the wall of the target vessel is closed. An independent cutter200 is then introduced through the wall of the graft vessel. The cutter200 itself may create an opening in the wall of the graft vessel throughwhich it can enter, or a separate implement may be used to create anopening in the wall of the graft vessel. The cutter 200 may beconfigured as described above, including a projection 208 extendingtherefrom, or may be configured differently. For example, the cutter 200may be J-shaped or L-shaped to facilitate creation of the openingbetween the graft vessel and the target vessel through the wall of thegraft vessel. The cutter 200 is manipulated relative to the connectionbetween the target vessel and the graft vessel to create an opening inthe wall of the target vessel at the junction therebetween. That is,registration is maintained between the cutter 200 and the junctionbetween the end of the graft vessel and the wall of the target vessel.The cutter 200 is then removed through the wall of the graft vessel, andthe opening in the wall of the graft vessel is sealed.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. For example, the tissue effector 400 may be connecteddirectly to the handle 302 without an intervening shaft 304, in asubstantially rigid or substantially non-rigid manner. As anotherexample, the mechanisms within the handle 302 may be reversed orotherwise rearranged, while maintaining their ability to actuate thetissue effector 400. It is to be understood that the invention is notlimited to the details of construction, the arrangements of components,and/or the process of performing anastomosis set forth in the abovedescription or illustrated in the drawings. Further, the invention isnot limited to the performance of anastomosis in the context of a CABGprocedure, nor it is limited to the anastomosis of two bodily vessels.Other tissue structures than vessels may be connected together withinthe body utilizing the present invention. Therefore, the invention isnot to be restricted or limited except in accordance with the followingclaims and their legal equivalents.

1. A method for connecting a graft vessel to a target vessel, eachvessel having a wall surrounding a lumen, comprising: providing aconnector holder; associating an end of the graft vessel with theconnector holder; positioning the connector holder outside of the lumenof the target vessel and outside the lumen of the graft vessel; andactuating the connector holder to secure the associated end of the graftvessel to the side of the target vessel.
 2. The method of claim 1,wherein said positioning includes positioning said connector holderagainst the outer surface of the wall of the target vessel.
 3. Themethod of claim 1, wherein said actuating includes deploying a pluralityof connectors, wherein at least part of each connector moves through thewall of the graft vessel and then into the wall of the target vessel. 4.The method of claim 3, further comprising providing an anvil andinserting at least part of said anvil into the lumen of the targetvessel; wherein said actuating includes deploying at least one saidconnector against said anvil.
 5. The method of claim 4, wherein saidanvil includes a sharp distal end; and wherein said inserting includespenetrating substantially intact tissue of the wall of the target vesselwith said sharp distal end of said anvil.
 6. The method of claim 4,wherein said anvil includes a blunt distal end; further comprisingcreating an aperture in the wall of the target vessel before saidinserting; wherein said inserting includes moving said blunt distal endof said anvil through the aperture.
 7. The method of claim 1, furthercomprising creating at least one flap at the associated end of the graftvessel.
 8. The method of claim 7, wherein said positioning brings eachflap into contact with the outer surface of the target vessel.
 9. Themethod of claim 7, wherein said actuating includes deploying a pluralityof connectors, wherein at least part of each connector moves througheach flap and then into the wall of the target vessel.
 10. The method ofclaim 1, further comprising creating an opening in the wall of thetarget vessel to allow fluid communication between the graft vessel andthe target vessel.
 11. A method for connecting a graft vessel to atarget vessel, each vessel having a wall surrounding a lumen,comprising: creating at least one flap at one end of the graft vessel;securing each flap to an outer surface of the target vessel; and makingan opening in the wall of the target vessel to allow fluid communicationbetween the graft vessel and the target vessel.
 12. The method of claim11, wherein said securing includes deploying a plurality of connectors,wherein at least part of each connector moves through each flap and intothe wall of the target vessel.
 13. The method of claim 12, wherein atleast one said connector is a staple.
 14. The method of claim 12,wherein said deploying includes plastically deforming at least one saidconnector.
 15. The method of claim 12, wherein said deploying includeselastically deforming at least one said connector.
 16. The method ofclaim 12, wherein said securing includes deploying at part of least onesaid connector through a corresponding flap and then into the wall ofthe target vessel.
 17. The method of claim 11, wherein said making isperformed from inside the lumen of the target vessel.
 18. A method forconnecting a graft vessel to a target vessel, each vessel having a wallsurrounding a lumen, comprising: creating at least one flap at one endof the graft vessel; providing a plurality of connectors; urging atleast part of at least one said connector through a flap and into thewall of the target vessel; and making an opening in the wall of thetarget vessel to allow fluid communication between the graft vessel andthe target vessel.
 19. The method of claim 18, wherein said urgingincludes urging at least one said connector at a different time than atleast one other said connector.
 20. The method of claim 18, furthercomprising providing a connector holder; wherein said urging isperformed by said connector holder.
 21. The method of claim 18, whereinsaid urging plastically deforms at least one said connector.
 22. Themethod of claim 18, wherein said urging causes elastic deformation of atleast one said connector.
 23. The method of claim 18, further comprisingproviding an anvil and inserting at least part of said anvil into thelumen of the target vessel; wherein said urging includes urging at leastone said connector against said anvil.
 24. The method of claim 18,wherein at least one said connector includes a base and plurality oftines connected to said base; and wherein said urging includes urgingsaid tines of at least one said connector through a flap and into thewall of the target vessel.